Report to Congress on Abnormal Occurrences; Fiscal Year 2010; Dissemination of Information, 38214-38219 [2011-16266]

Download as PDF 38214 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices For the Nuclear Regulatory Commission. Thomas H. Boyce, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011–16273 Filed 6–28–11; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2011–0132] mstockstill on DSK4VPTVN1PROD with NOTICES Report to Congress on Abnormal Occurrences; Fiscal Year 2010; Dissemination of Information Section 208 of the Energy Reorganization Act of 1974 (Pub. L. 93– 438) defines an abnormal occurrence (AO) as an unscheduled incident or event that the U.S. Nuclear Regulatory Commission (NRC) determines to be significant from the standpoint of public health or safety. The Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 104–68) requires that AOs be reported to Congress annually. During fiscal year 2010, fifteen events that occurred at facilities licensed or otherwise regulated by the NRC and/or Agreement States were determined to be AOs. This report describes eight events at NRC-licensed facilities. The first event involved radiation exposure to an embryo/fetus. The other seven events occurred at NRC-licensed or regulated medical institutions and are medical events as defined in Title 10, Part 35, of the Code of Federal Regulations (10 CFR part 35). The report also describes seven events at Agreement State-licensed facilities. Agreement States are the 37 States that currently have entered into formal agreements with the NRC pursuant to Section 274 of the Atomic Energy Act (AEA) to regulate certain quantities of AEA-licensed material at facilities located within their borders. The first two Agreement State-licensee events involved radiation exposure to an embryo/fetus. The other five Agreement State-licensee events were medical events as defined in 10 CFR part 35 and occurred at medical institutions. As required by Section 208, the discussion for each event includes the date and place, the nature and probable consequences, the cause or causes, and the actions taken to prevent recurrence. Each event is also being described in NUREG–0090, Vol. 33, ‘‘Report to Congress on Abnormal Occurrences: Fiscal Year 2010.’’ This report is available electronically at the NRC Web site at http://www.nrc.gov/ reading-rm/doc-collections/nuregs/staff/ . VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 Three major categories of events are reported in this document—I. For All Licensees, II. For Commercial Nuclear Power Plant Licensees, and III. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events. The full report, which is available on the NRC Web site, provides the specific criteria for determining when an event is an AO. It also discusses ‘‘Other Events of Interest,’’ which does not meet the AO criteria but has been determined by the Commission to be included in the report. The event identification number begins with ‘‘AS’’ for Agreement State AO events and ‘‘NRC’’ for NRC AO events. Management Agency that the administration had occurred 3 years earlier. The Illinois Emergency Management Agency calculated an estimated dose to the fetus of 860 mSv (86 rem) and the fetal thyroid of over 1,000,000 mSv (100,000 rem). A fullterm child was subsequently born in August 2007 without a thyroid. The child was immediately placed on replacement hormone therapy and continues such treatment. Cause(s)—The cause of the event was found to be a combination of miscommunication and failure of the licensee to conduct an independent confirmatory pregnancy test. I. For All Licensees Actions Taken To Prevent Recurrence Licensee—The licensee has subsequently made procedural changes to the interview process for screening patients for iodine-131 treatment. This policy includes a confirmatory negative pregnancy test. In addition, the licensee identified the significant delay in reporting the event to the Illinois Emergency Management Agency as not knowing the reporting requirement for this type of event. State—The Illinois Emergency Management Agency conducted an investigation of the event and issued a Notice of Violation (NOV) for the licensee’s failure to report the event. The Illinois Emergency Management Agency is considering rulemaking to require the performance of testing to determine pregnancy prior to administration of iodine-131. A. Human Exposure to Radiation From Licensed Material During this reporting period, one event at an NRC-licensed or regulated facility and two events at Agreement State-licensed facilities were significant enough to be reported as AOs. Although these events occurred at medical facilities, they involved unintended exposures to individuals who were not patients. Therefore, these events belong under the criteria I.A, ‘‘For All Licensees’’ category as opposed to the criteria III.C, ‘‘For Medical Licensees’’ category. AS10–01 Human Exposure to Radiation at Mohamed Megahy MD, Ltd in Maryville, Illinois Date and Place—May 1, 2007 (reported on June 17, 2010), Maryville, Illinois. Nature and Probable Consequences— Mohamed Megahy MD, Ltd (the licensee) indicated that on May 1, 2007, a patient was given 3,807 MBq (102.9 mCi) of iodine-131 as a treatment for the recurrence of thyroid cancer. On June 11, 2007, the licensee was contacted by the patient’s obstetrician/gynecologist (OB/GYN) who advised them that the patient was 25–27 weeks (6 months) pregnant at the time of the iodine-131 administration. At the time of administration, the patient indicated to the licensee that she was not pregnant, and the licensee did not perform an independent test. In June 2010, the Illinois Emergency Management Agency was contacted by the licensee and requested to make a dose estimate to a fetus as a result of administration of iodine-131 to a patient who was later found to be pregnant. When the Illinois Emergency Management Agency requested additional information to determine the appropriate parameters of the event, the licensee advised the Illinois Emergency PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 AS10–02 Human Exposure to Radiation at Mercy Medical Center in Durango, Colorado Date and Place—March 16, 2010, Durango, Colorado. Nature and Probable Consequences— Mercy Medical Center (the licensee) reported that a therapeutic dose of 1,110 MBq (30 mCi) of iodine-131 for hyperthyroidism resulted in a dose to an embryo of 80 mGy (8 rem) whole body. Prior to the treatment, the patient informed the licensee’s staff that she was not pregnant and the licensee’s staff administered a pregnancy test as a routine precaution. The pregnancy test yielded a negative result. Based on the negative pregnancy test results and the patient’s interview responses, the licensee administered iodine-131 to the patient. On April 26, 2010, the patient performed a home pregnancy test that resulted in a positive test result. The patient’s pregnancy was confirmed with a positive blood serum pregnancy test on April 27, 2010. The patient’s OB/ GYN estimated that conception E:\FR\FM\29JNN1.SGM 29JNN1 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices occurred on March 13, 2010 (about 1 week pregnant at the time of administration). A consulting medical physicist reviewed the case and estimated the embryonic exposure (whole body) at 53 to 92 mGy (5.3 to 9.2 rem). The possibility of embryonic thyroid exposure was also investigated and determined to be insignificant due to the early stage of embryonic development. At this dose and administration time in relation to the embryonic development (blastogenesis), the licensee determined that no adverse impact will be likely on subsequent embryonic or fetal development and that subsequent health risks were unlikely. The patient was informed of the dose estimates and potential risks and she elected to continue the pregnancy. Cause(s)—The cause of this event was the close proximity of conception, which resulted in a negative pregnancy test, to the administration of the iodine131. mstockstill on DSK4VPTVN1PROD with NOTICES Actions Taken To Prevent Recurrence Licensee—To help prevent recurrence, the licensee added additional questions to the screening process to help identify patients that might be pregnant even though all procedures to prevent this occurrence were followed. State—The State conducted an investigation and concurs with the licensee that a reasonable standard of care was met and, consequently, no enforcement action is warranted. NRC10–01 Human Exposure to Radiation at Tripler Army Medical Center in Honolulu, Hawaii Date and Place—June 7, 2010, Honolulu, Hawaii. Nature and Probable Consequences— Tripler Army Medical Center (TAMC) (the licensee) reported that a female patient underwent a therapeutic administration of iodine-131 for thyroid ablation therapy. Prior to the treatment, the patient informed the licensee’s staff that she was not pregnant and the licensee’s staff administered a pregnancy test as a routine precaution. The pregnancy test yielded a negative result. Based on the negative pregnancy test results and the patient’s interview responses, the licensee administered iodine-131 to the patient. On July 8, 2010, the patient became aware that she was pregnant and informed the licensee and her physician. On August 3, 2010, an ultrasound was performed on the patient and a determination was made that the actual date of conception was June 1, 2010 (about 1 week pregnant at VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 time of administration). The TAMC radiation safety officer (RSO) estimated the embryonic dose to be 41.27 cGy (41.27 rad) and concluded that the exposure of the embryo in the first 2 weeks following conception is not likely to result in malformation or embryo/ fetal death despite the fact that the central nervous system and the heart are beginning to develop in the third week. The NRC contracted with a medical consultant to perform an independent medical evaluation of this embryo/fetal overexposure event. The consultant’s report agreed with the TAMC conclusions with the exception that the medical consultant did not want to rule out the chance of embryo/fetal malformation. Cause(s)—The cause of this event was the close proximity of conception, which resulted in a negative pregnancy test, to the administration of the iodine131. Actions Taken To Prevent Recurrence Licensee—The patient consent form has been updated to reflect that the pregnancy test may not show a positive result until the embryo has implanted, which may not occur until 7–10 days after conception. In future consultations, the clinic plans to ask the patient to refrain from any action that may lead to pregnancy during the period immediately prior to therapeutic radioisotope administration. NRC—The NRC conducted an inspection on October 13–14, 2010, and concluded there were no violations of NRC requirements associated with this event. II. Commercial Nuclear Power Plant Licensees During this reporting period, no events at commercial nuclear power plants in the United States were significant enough to be reported as AOs. III. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events C. Medical Licensees During this reporting period, seven events at NRC-licensed or regulated facilities and five events at Agreement State-licensed facilities were significant enough to be reported as AOs. AS10–03 Medical Event at Mercy St. Vincent Medical Center in Toledo, Ohio Date and Place—November 8, 2005 (reported on March 3, 2010), Toledo, Ohio. Nature and Probable Consequences— Mercy St. Vincent Medical Center (the licensee) reported that a medical event PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 38215 occurred associated with a brachytherapy seed implant procedure to treat prostate cancer. The patient was prescribed to receive a total dose of 160 Gy (16,000 rad) to the prostate using 67 iodine-125 seeds. Instead, the patient’s sigmoid colon received at least the full prescription dose of 160 Gy (16,000 rad) and a significant portion of the bladder base including the region of the urethral orifices received at least 108 Gy (10,800 rad) (wrong treatment sites). The patient and referring physician were informed of this event. On March 3, 2010, the Ohio Department of Health (ODH) performed an inspection of the licensee and noted that the licensee had not reported this medical event to the State and the NRC. The licensee had not identified the medical event as a reportable event and did not investigate it to determine a cause. Subsequently, the licensee reported the medical event to the NRC. The licensee confirmed that 13 of the permanent iodine-125 seeds were improperly positioned in the bladder and subsequently removed from the patient’s bladder immediately after the procedure. A post-implant dose calculation showed that the prostate received a dose of 15.43 Gy (1,543 rad), or 9.6 percent of the prescribed dose. The patient chose to then receive an external beam treatment with a linear accelerator to treat the tumor. About 13 months after the brachytherapy procedure, the patient developed rectosigmoid bleeding that required hospitalization and argon laser coagulopathy. In August 2010, ODH ordered an independent medical expert evaluation of the event. The independent medical expert concluded that the subsequent delivery of external beam radiotherapy may have contributed to the rectosigmoid damage, but the high dose from the brachytherapy procedure almost certainly was the primary cause of the damage. Cause(s)—The cause of the medical event was the failure of the licensee to adequately visualize the prostate prior to the implant procedure. Actions Taken To Prevent Recurrence Licensee—Corrective actions taken by the licensee included training of the RSO, medical physicist, clinical director, and radiation oncologists on ODH regulations concerning medical events. New procedures were also developed for brachytherapy seed implant procedures. State—In March 2010, ODH conducted a special inspection of the licensee and issued an NOV. The NOV required the licensee to perform a self E:\FR\FM\29JNN1.SGM 29JNN1 38216 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices audit of all brachytherapy cases performed since November 2004, which revealed seven additional medical events that were not reported. In June 2010, an Adjudication Order and administrative penalty of $25,000 were issued to the licensee. mstockstill on DSK4VPTVN1PROD with NOTICES NRC10–02 Medical Event at Chippenham & Johnston-Willis Medical Center in Richmond, Virginia Date and Place—December 16, 2008, Richmond, Virginia. Nature and Probable Consequences— Chippenham & Johnston-Willis (CJW) Medical Center (the licensee) reported a medical event with its gamma stereotactic radiosurgery (GSR) unit. A patient being treated for trigeminal neuralgia (inflammation of the nerve) was prescribed a treatment of 40 Gy (4,000 rad) to the right trigeminal nerve but received the treatment dose to the left trigeminal nerve (wrong treatment site). The patient and referring physician were informed of this event. The licensee noted that on the day of the treatment, the top portion of the written directive correctly documented the prescribed treatment site; however, while the staff was preparing the daily patient treatment log, it was inadvertently annotated that the dose was to be delivered to the left trigeminal nerve. This error was carried through by the medical physicist during preparation of the patient’s treatment plan and completion of the bottom part of the written directive. Upon completion of the procedure and after reviewing the patient’s file, the treatment team identified the inadvertent treatment of the left trigeminal nerve. The NRC contracted medical consultant concluded that although no actual consequences resulted, an unlikely injury to the brain stem was possible due to high radiation dose to a tiny volume of the brain stem tissue and an increased risk of cataract formation. Cause(s)—The cause of the medical event was the licensee’s failure to have adequate procedures that verify the location of treatment sites and ensure that any inconsistencies in the written directives are resolved prior to administration. Actions Taken To Prevent Recurrence Licensee—The licensee revised their GSR treatment procedures to affirm that (1) a ‘‘Physician Order’’ will be the primary source of documentation of the treatment site and will accompany the patient through the entire course of the treatment, (2) the radiation oncologist and the neurosurgeon will independently verify and document the VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 treatment site, (3) the nurse and the medical physicist will confirm that the treatment site identified by the radiation oncologist in the written directive and the neurosurgeon’s ‘‘physician order’’ both match, (4) the neurosurgeon will mark the treatment site with ink in the presence of a nurse, and (5) a ‘‘TimeOut’’ process involving independent verification of the final treatment plan by each of the four members of the clinical team (who are required to signoff their presence and acceptance of time-out in the presence of the patient before moving ahead with the treatment) will be used with the patient or the patient’s authorized representative to confirm the treatment site. NRC—The NRC initiated an inspection on December 18, 2008. The NRC completed the inspection on November 30, 2009, and issued one Severity Level III violation to the licensee on January 21, 2010. NRC10–03 Medical Event at Virtua Health System in Marlton, New Jersey Date and Place—January 19, 2009, Marlton, New Jersey. Nature and Probable Consequences— Virtua Health System (the licensee) reported that a medical event occurred associated with a brachytherapy seed implant procedure to treat prostate cancer. The patient was prescribed to receive a total dose of 145 Gy (14,500 rad) to the prostate using 93 iodine-125 seeds. Instead, the patient received an approximate dose of 12.2 Gy (1,220 rad) to the rectum (wrong treatment site). The patient and referring physician were informed of this event. On January 19, 2009, the urologist inserted needles in the patient’s prostate gland under transrectal ultrasound guidance while the radiation oncologist left the operating room to obtain the radioactive seeds. The licensee’s staff (including the authorized medical physicist [AMP]) questioned the accuracy of prostate visualization prior to implantation of the seeds but took no action to resolve the question. On February 23, 2009, following a postimplant computed tomography (CT) scan, it was noted that some mispositioning of the sources occurred and the patient was notified that additional treatment may be necessary. On March 19, 2009, the AMP reviewed the case and determined that 100 percent of the seeds were implanted outside of the prostate, which received about 10 Gy (1,000 rad). The NRC contracted with a medical consultant who concluded that although the probability of long-lasting negative health effects to the patient is low, an increased risk of impotency and fibrosis PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 was possible due to the high radiation dose. Cause(s)—The cause of the medical event was failure of the medical implant team to adequately visualize and identify the prostate prior to the implant. Actions Taken To Prevent Recurrence Licensee—The licensee revised its policy and procedures to require that (1) all members of the implant team be present before the patient is brought to the operating room and placed under anesthesia, (2) the AMP be included in the pre-implantation ultrasound, (3) the authorized user consult with the urologist before needle insertion, (4) both the radiation oncologist and the urologist agree on the positioning and the visualizing of the target anatomy, (5) any objection or question by an implant team member is cause for stopping the implant and performing a review, and 6) the implant be stopped if there are any ultrasound image questions. The licensee’s staff was also trained on the revised procedures, the definition and reporting requirements of a medical event, and the communication of any CT scan abnormalities or seed misplacement to the RSO. NRC—The NRC initiated an inspection on March 20, 2009. The NRC completed the inspection on August 26, 2009, and issued one Severity Level III violation to the licensee on October 21, 2009. NRC10–04 Medical Event at Nanticoke Memorial Hospital, Seaford, Delaware Date and Place—March 5, 2009 (reported on July 15, 2009), Seaford, Delaware. Nature and Probable Consequences— Nanticoke Memorial Hospital (the licensee) reported that a medical event occurred involving a brachytherapy seed implant procedure to treat prostate cancer. The patient was prescribed a total dose of 145 Gy (14,500 rad) to the prostate using 61 iodine-125 seeds. Instead, the patient received an approximate prostate dose of 26 Gy (2,600 rad) (18 percent of the prescribed dose) and a dose of 139 Gy (13,900 rad) to unintended tissue (wrong treatment site). The patient and referring physician were informed of this event. The seeds were implanted under ultrasound guidance using an axial view; however, following the implant, the urologist performed a cystoscopy to remove 22 of the seeds from the bladder. When the patient returned to the hospital for a post-implant CT scan, the images revealed that 32 seeds were displaced superiorly to the prostate and 7 seeds were implanted in the prostate. E:\FR\FM\29JNN1.SGM 29JNN1 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices The NRC contracted with a medical consultant who concluded that no significant adverse health effects to the patient were expected. Cause(s)—The cause of the medical event was due to a miscalculation of the prostate depth in relation to the skin surface due to possible patient movement during the procedure. mstockstill on DSK4VPTVN1PROD with NOTICES Actions Taken To Prevent Recurrence Licensee—The licensee revised its prostate implant procedure to include the use of both the axial and sagittal views of an ultrasound probe to determine prostate depth. In addition, the licensee revised its medical event policy to ensure timely reporting of medical events and to clearly state the parameters under which a medical event must be reported. The licensee provided training on the revised policies and procedures to its staff. NRC—The NRC initiated an inspection on July 19, 2009. The NRC completed the inspection on January 6, 2010, and issued one Severity Level III violation to the licensee on February 2, 2010. AS10–04 Medical Event at Hoag Memorial Hospital Presbyterian in Newport Beach, California Date and Place—March 20, 2009, Newport Beach, California. Nature and Probable Consequences— Hoag Memorial Hospital Presbyterian (the licensee) reported that a medical event occurred associated with its GSR unit. A patient being treated for an acoustic neuroma was scheduled to receive between 11 and 18 Gy (1,100 and 1,800 rads) to an intended neuroma volume of 0.08 cm3 but, due to an unintended shift in the treatment volume of about 2 mm, only about onehalf of the neuroma received the treatment dose and an adjacent temporal bone volume of 0.04 cm3 received the treatment dose (wrong treatment site). The other half of the neuroma received between 3 and 11 Gy (300 and 1,100 rads). The patient and physician were informed of this event. The unintended shift in treatment volume occurred due to a misaligned fiduciary marker (indicator) box during a CT scan used in the treatment planning process. The misalignment occurred because one alignment pin of four on the indicator box was not fully seated in the stereotactic frame attached to the patient’s head, resulting in the indicator box not being correctly aligned. The alignment pin error was not detected until the conclusion of the treatment. The additional dose to the temporal bone because of the alignment error is not expected to result in any VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 significant adverse health effect to the patient. Cause(s)—The medical event is believed to have been caused by human error in not ensuring the CT indicator box was properly installed at the time of the CT scan. It is not known if the improper installation occurred when the technologist positioned the indicator box in the stereotactic frame or whether the indicator box became misaligned during patient positioning in preparation for the CT scan. Actions Taken To Prevent Recurrence Licensee—The licensee has retrained all CT technologists concerning the proper placement of the CT indicator box. Also, because use of CT imaging for GSR treatment is infrequent (normally MRI is used), the licensee now requires that a GSR qualified medical physicist verify the placement of the CT indicator box immediately prior to all CT imaging that will be used for GSR treatment planning. State—On June 22, 2009, the California Department of Public Health (CDPH) issued an NOV related to this event. Subsequently, CDPH received dosimetry information which they used to interpret the event as not meeting the AO criteria; however, CDPH was not certain of this determination and asked the NRC for a final determination. On July 1, 2010, after the NRC Medical Radiation Safety Team (MSRT) had performed a careful analysis of the event along with the dosimetry data, the NRC determined that the event met the AO criteria. AS10–05 Medical Event at Marshfield Clinic in Marshfield, Wisconsin Date and Place—June 2005 to May 2007, (reported on July 8, 2010) Marshfield, Wisconsin. Nature and Probable Consequences— In July 2010, the Marshfield Clinic (the licensee) reviewed all prostate brachytherapy cases performed under its license in the past 7 years. The review resulted in the identification of nine medical events involving permanent implants of iodine-125 for prostate brachytherapy where the total dose delivered differed from the prescribed dose by 20 percent or more, or another organ received at least 50 percent more dose than intended. The three medical events involved planned doses to the prostate of 120 Gy (12,000 rad), 160 Gy (16,000 rad), and 160 Gy (16,000 rad). The licensee assumes an identical planned dose to the urethra. However, these treatments resulted in actual doses to the urethra of 191.6 Gy (19,160 rad), 258.1 Gy (25,810 rad), and 242.6 Gy (24,260 rad), which were PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 38217 overdoses of 59.7, 61.3, and 51.6 percent, respectively. The licensee notified the affected patients and referring physicians. The authorized user physicians had previously determined that patients would not suffer significant health effects for urethral doses below 400 Gy (40,000 rad). Because the urethra penetrates through the center of the prostate and the prostate itself is a small gland, a balance exists between reducing the dose to the urethra and delivering the prescribed dose to the prostate. The doses delivered to the patients in question were well within the 400 Gy (40,000 rad) urethral tolerance dose, and the licensee considered the treatments to be clinically acceptable. Cause(s)—The licensee suspects that the implants deviated from their intended tracks after insertion into the prostate, causing the seeds to be deposited closer to the urethra. Actions Taken To Prevent Recurrence Licensee—Corrective actions included developing a procedure for ensuring that treatments were delivered in accordance with the written directive, planning treatments to D90 (minimum dose received by 90 percent of CTdefined prostate volume) values of 100– 110 percent, using the same written directive form at each site that performs brachytherapy, increasing ultrasound and fluoroscopy visualization during prostate implants and providing additional training to personnel. State—The Wisconsin Department of Health Services determined that Marshfield Clinic did not have a procedure for evaluating whether the dose delivered in a prostate brachytherapy treatment was in accordance with the written directive. In addition, the licensee did not have criteria for identifying a medical event for prostate brachytherapy. The licensee has been cited for several items of noncompliance. NRC10–05 Medical Event at Yale NewHaven Hospital, New Haven, Connecticut Date and Place—August 5, 2009, New Haven, Connecticut. Nature and Probable Consequences— Yale New-Haven Hospital (the licensee) reported that a medical event occurred associated with its GSR unit. A patient being treated for brain metastases was prescribed 18 Gy (1,800 rad). However, while treating a patient earlier in the day, an equipment malfunction occurred with the GSR unit that resulted in a positioning shift of the x-axis by 4.5 mm. The positioning shift in the x-axis E:\FR\FM\29JNN1.SGM 29JNN1 38218 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices resulted in an underdose to the treatment site and an overdose to a wrong treatment site. The patient and physician were informed of this event. The malfunction occurred following the treatment of the first patient on August 5, 2009. The automatic positioning system (APS) malfunctioned and, after discussion with the GSR manufacturer, the position error codes were cleared by the AMP. A second patient was treated for multiple brain metastases later that day. The GSR service personnel noted on August 5, 2009, that the APS positioning was off by about 5 mm. After further evaluation, the manufacturer determined that a position shift (offset) occurred when licensee personnel accepted an error message concerning position deviation. The NRC contracted with a medical consultant who concluded that no clinically significant side effects from radiation damage to the wrong treatment sites would be expected. Cause(s)—The cause of the medical event was failure of licensee personnel to verify that the APS coordinates were in accordance with the written directive. Actions Taken To Prevent Recurrence Licensee—The licensee issued a memorandum to all personnel involved in GSR treatments to require visual verification of the physical coordinates against the electronic coordinates before the start and at the end of each treatment run. The licensee also retrained all GSR personnel on the importance of fully understanding error conditions and reviewing unexpected errors with other staff involved in the treatment (e.g., radiation oncologist, AMP, etc.) prior to clearing any unexpected error. NRC—The NRC initiated an inspection on August 13, 2009. The NRC completed the inspection on April 7, 2010, and issued one Severity Level III violation to the licensee on May 21, 2010. mstockstill on DSK4VPTVN1PROD with NOTICES NRC10–06 Medical Event at Valley Hospital in Paramus, New Jersey Date and Place—July 29, 2009, Paramus, New Jersey. Nature and Probable Consequences— Valley Hospital (the licensee) reported that a medical event occurred associated with a brachytherapy seed implant procedure to treat prostate cancer. The patient was prescribed a total dose of 65 Gy (6,500 rad) to the prostate using 46 cesium-131 seeds. Instead, the licensee determined that an unintended volume (30.1 ml) of soft tissue received 100 percent of the prescribed prostate dose. VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 The patient and referring physician were informed of this event. On August 6, 2009, the patient returned to the hospital for a postimplant CT scan. The images revealed that the seeds were implanted in soft tissue 4 to 5 cm from the prostate. Postimplant dosimetry calculations indicated that none of the prostate received the prescribed dose of 6,500 cGy (6,500 rad). The NRC contracted with a medical consultant who concluded that the additional dose can increase the risk of soft tissue fibrosis or increase the risk of impotency. Cause(s)—The cause of the medical event was the licensee’s failure to identify the position of the prostate due to the patient’s unusual anatomy and obesity. Actions Taken To Prevent Recurrence Licensee—The licensee revised their prostate implant procedures to include steps to ensure that the prostate and surrounding anatomy is adequately visualized prior to implant. NRC—The NRC initiated an inspection on August 13, 2009. The NRC completed the inspection on October 29, 2009, and determined that no violations of NRC requirements occurred. NRC10–07 Medical Event at Christiana Care Health Center in Wilmington, Delaware Date and Place—January 18, 2010, Wilmington, Delaware. Nature and Probable Consequences— Christiana Care Heath Center (the licensee) reported that a patient was prescribed a high dose-rate (HDR) mammosite (brachytherapy) multilumen catheter treatment of 34 Gy (3,400 rad) over a 5-day period to the left breast. The patient received an average dose of 17 Gy (1,700 rad) to 100 cm3 of unintended breast tissue; 68 Gy (6,800 rad) to 7.5 cm3 of unintended skin and underlying tissue; and 3.4 Gy (340 rad) to 35 cm3 of intended breast tissue. The patient and referring physician were informed of this event. On February 22, 2010, during a follow-up examination, the patient complained about skin reddening on the external breast. In reviewing the treatment plan, it was discovered that the AMP performed measurements using a source position simulator (SPS) measurement tool following a CT scan to determine the treatment distance for each catheter. The catheter distances were recorded and confirmed with two manufacturer representatives that were present at the time of the treatment. However, it was noted that an incorrect measurement caused the placement of PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 the radioactive source 10 cm proximal to the intended position. The NRC contracted medical consultant concluded that the dose that was administered to the unintended left breast tissue is unlikely to result in any significant or unusual adverse effect. However, a significant risk exists that local tumor recurrence could occur if additional intervention is not performed. Cause(s)—The cause of the medical event was human error in the failure to identify that the measurement tool was functioning improperly and to identify an incorrect measurement distance. Actions Taken To Prevent Recurrence Licensee—The licensee revised its procedures for HDR brachytherapy to require a double-check of all patient measurements, a daily and monthly quality assurance requirement to confirm that the SPS tool is functioning properly, and a process to ensure that all members of the treatment team agree on the specifics of the treatment. In addition, the licensee acquired a new SPS tool, developed and posted a reference table at the HDR control console, provided training on revised procedures to staff involved in the HDR program (to be repeated annually), and implemented a ‘‘New Product’’ committee to review all new product plans. NRC—The NRC conducted an inspection on July 12, 2010, and issued one Severity Level III violation to the licensee on August 24, 2010. AS10–06 Medical Event at Mary Bird Perkins Cancer Center in Baton Rouge, Louisiana Date and Place—March 15, 2010, Baton Rouge, Louisiana. Nature and Probable Consequences— Mary Bird Perkins Cancer Center (the licensee) reported that a medical event occurred associated with a brachytherapy seed implant procedure to treat prostate cancer. The patient was prescribed a total dose of 145 Gy (14,500 rad) to the prostate using iodine-125 seeds. Instead, the patient received a dose of 39.55 Gy (3,955 rad) to the rectum, 40.94 Gy (4,094 rad) to the urethra, and 6 Gy (600 rad) to the bladder (wrong treatment sites). The patient and referring physician were informed of this event. During the review of this event, the licensee determined that a positioning error occurred and the dose was delivered about 3.0 cm away from the targeted prostate gland. The estimated dose to the prostate gland was 12.88 Gy (1,288 rad). The licensee concluded that E:\FR\FM\29JNN1.SGM 29JNN1 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices Actions Taken To Prevent Recurrence no significant adverse health effect to the patient is expected. Actions Taken To Prevent Recurrence Licensee—The licensee modified its procedure to insert the needles that hold the prostate in place prior to obtaining the ultrasound images instead of immediately before the seed needles are inserted. In addition, the sagittal image will be captured at the time of planning image acquisition and confirmed periodically throughout the case, and the radiation oncologist will personally confirm the location of the reference base prior to dispensing the first seed. State—The Louisiana Department of Environmental Quality conducted an investigation, reviewed the licensee’s corrective actions, and found the corrective actions to be adequate. mstockstill on DSK4VPTVN1PROD with NOTICES AS10–07 Medical Event at Mayo Clinic in Rochester, Minnesota Date and Place—March 23, 2010, Rochester, Minnesota. Nature and Probable Consequences— The Mayo Clinic (the licensee) reported a medical event associated with an HDR biliary treatment for liver carcinoma containing 329 GBq (8.9 Ci) of iridium192. A patient was prescribed to receive four fractionated doses totaling 16 Gy (1,600 rad) to the liver. The treatment to the liver should have produced an estimated dose to the duodenum (wrong treatment site) of 1.2 Gy (120 rad) but as a result of the event it received a dose of about 10 Gy (1,000 rad). The patient and referring physician were informed of this event. During the second fractioned treatment, the measurement cable was inserted into the catheter and it was noted that it extended about 17 cm beyond the programmed treatment distance used during the first fractioned treatment. It was concluded that the measurement wire on the first treatment had met with some resistance at a tight bend and that it was not at the end of the catheter. This resulted in overdosing the duodenum (wrong treatment site). Upon discovery of the treatment distance error and overdose, the licensee changed the written directive to add a fifth fractioned treatment to correct for the underdose of the liver. A lesser total dose to the liver was given because of concerns regarding the dose already received by the duodenum. The authorized user concluded that no chronic health effect to the patient is expected. Cause(s)—The medical event was caused by human error in failing to verify that the correct catheter length was entered into the HDR unit. VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 38219 licensee’s corrective actions. The NRC has retained the services of an independent medical consultant to determine if any significant health effects to the patient are expected. Licensee—The licensee committed to taking several corrective actions including the imaging of inserted catheters prior to treatments and performing catheter length checks prior to HDR treatments. State—On April 6, 2010, the Minnesota Department of Health (MDH) staff performed a reactive inspection of the licensee’s HDR program. The MDH approved the licensee’s corrective actions and did not take enforcement action. Dated at Rockville, Maryland, this 23rd day of June, 2011. For the Nuclear Regulatory Commission. Andrew L. Bates, Acting Secretary of the Commission. NRC10–08 Medical Event at Providence Hospital in Novi, Michigan OVERSEAS PRIVATE INVESTMENT CORPORATION Date and Place—August 30, 2010, Novi, Michigan. Nature and Probable Consequences— Providence Hospital (the licensee) reported that a medical event occurred associated with an anal brachytherapy treatment using 32 seeds containing iodine-125. The intended dose was 90 Gy (9,000 rad) to the tumor. Instead, the patient’s seminal vesicle received 19.79 Gy (1,979 rad) more than intended and the bladder received 3.68 Gy (368 rad) more than intended. The patient and referring physician were informed of this event. On September 1, 2010, a follow-up CT scan showed that the permanent implants had been inserted about 4 cm from the intended location. The licensee reported that the tumor near the anus and rectum received a maximum dose of 8 Gy (800 rad). The licensee calculated the dose difference to the surrounding tissue as a result of the improper permanent implant placement. The licensee concluded that no significant adverse health effect to the patient is expected. Cause(s)—The licensee determined that the cause of the event was that they did not use tissue markers to confirm source placement and the insertion needle did not have a visible mark to ensure proper depth placement. [OMB–3420–0011; OPIC–115] Actions Taken To Prevent Recurrence Licensee—Procedures were modified to administer sources as prescribed in the written directive as follows: (1) Any interstitial procedure that requires the use of fluoroscopy alone will be done with the use of tissue markers to confirm source placement, and (2) interstitial procedures that use fluoroscopy alone will have needle depth verified. The licensee completed training of licensee staff on the event and the corrective actions by October 1, 2010. NRC—The NRC’s Region III staff reviewed and concurred on the PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 [FR Doc. 2011–16266 Filed 6–28–11; 8:45 am] BILLING CODE 7590–01–P Submission for OMB Review Overseas Private Investment Corporation (OPIC). ACTION: Request for approval. AGENCY: Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to publish a Notice in the Federal Register notifying the public that the agency has prepared an information collection for OMB review and approval. {Comments were solicited in the 60 day notice, posted on [October 2, 2007], and no comments were received.} DATES: This 30-day notice is to inform the public, that this collection is being submitted to OMB for approval. ADDRESSES: Copies of the subject form may be obtained from the Agency submitting officer. FOR FURTHER INFORMATION CONTACT: OPIC Agency Submitting Officer: Essie Bryant, Record Manager, Overseas Private Investment Corporation, 1100 New York Avenue, NW., Washington, DC 20527; (202) 336–8563. SUMMARY: Summary Form Under Review Type of Request: Revised form. Title: Application for Financing. Form Number: OPIC–115. Frequency of Use: Once per investor per project. Type of Respondents: Business or other institution (except farms); individuals. Standard Industrial Classification Codes: All. Description of Affected Public: U.S. companies or citizens investing overseas. Reporting Hours: 9 hours per project. Number of Responses: 190 per year. Federal Cost: $12,754. Authority for Information Collection: Sections 231, 234(a), 239(d), and 240A of the Foreign Assistance Act of 1961, as amended. E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38214-38219]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16266]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[NRC-2011-0132]


Report to Congress on Abnormal Occurrences; Fiscal Year 2010; 
Dissemination of Information

    Section 208 of the Energy Reorganization Act of 1974 (Pub. L. 93-
438) defines an abnormal occurrence (AO) as an unscheduled incident or 
event that the U.S. Nuclear Regulatory Commission (NRC) determines to 
be significant from the standpoint of public health or safety. The 
Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 104-68) 
requires that AOs be reported to Congress annually. During fiscal year 
2010, fifteen events that occurred at facilities licensed or otherwise 
regulated by the NRC and/or Agreement States were determined to be AOs.
    This report describes eight events at NRC-licensed facilities. The 
first event involved radiation exposure to an embryo/fetus. The other 
seven events occurred at NRC-licensed or regulated medical institutions 
and are medical events as defined in Title 10, Part 35, of the Code of 
Federal Regulations (10 CFR part 35). The report also describes seven 
events at Agreement State-licensed facilities. Agreement States are the 
37 States that currently have entered into formal agreements with the 
NRC pursuant to Section 274 of the Atomic Energy Act (AEA) to regulate 
certain quantities of AEA-licensed material at facilities located 
within their borders. The first two Agreement State-licensee events 
involved radiation exposure to an embryo/fetus. The other five 
Agreement State-licensee events were medical events as defined in 10 
CFR part 35 and occurred at medical institutions. As required by 
Section 208, the discussion for each event includes the date and place, 
the nature and probable consequences, the cause or causes, and the 
actions taken to prevent recurrence. Each event is also being described 
in NUREG-0090, Vol. 33, ``Report to Congress on Abnormal Occurrences: 
Fiscal Year 2010.'' This report is available electronically at the NRC 
Web site at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/
.
    Three major categories of events are reported in this document--I. 
For All Licensees, II. For Commercial Nuclear Power Plant Licensees, 
and III. Events at Facilities Other Than Nuclear Power Plants and All 
Transportation Events. The full report, which is available on the NRC 
Web site, provides the specific criteria for determining when an event 
is an AO. It also discusses ``Other Events of Interest,'' which does 
not meet the AO criteria but has been determined by the Commission to 
be included in the report. The event identification number begins with 
``AS'' for Agreement State AO events and ``NRC'' for NRC AO events.

I. For All Licensees

A. Human Exposure to Radiation From Licensed Material

    During this reporting period, one event at an NRC-licensed or 
regulated facility and two events at Agreement State-licensed 
facilities were significant enough to be reported as AOs. Although 
these events occurred at medical facilities, they involved unintended 
exposures to individuals who were not patients. Therefore, these events 
belong under the criteria I.A, ``For All Licensees'' category as 
opposed to the criteria III.C, ``For Medical Licensees'' category.
AS10-01 Human Exposure to Radiation at Mohamed Megahy MD, Ltd in 
Maryville, Illinois
    Date and Place--May 1, 2007 (reported on June 17, 2010), Maryville, 
Illinois.
    Nature and Probable Consequences--Mohamed Megahy MD, Ltd (the 
licensee) indicated that on May 1, 2007, a patient was given 3,807 MBq 
(102.9 mCi) of iodine-131 as a treatment for the recurrence of thyroid 
cancer. On June 11, 2007, the licensee was contacted by the patient's 
obstetrician/gynecologist (OB/GYN) who advised them that the patient 
was 25-27 weeks (6 months) pregnant at the time of the iodine-131 
administration. At the time of administration, the patient indicated to 
the licensee that she was not pregnant, and the licensee did not 
perform an independent test.
    In June 2010, the Illinois Emergency Management Agency was 
contacted by the licensee and requested to make a dose estimate to a 
fetus as a result of administration of iodine-131 to a patient who was 
later found to be pregnant. When the Illinois Emergency Management 
Agency requested additional information to determine the appropriate 
parameters of the event, the licensee advised the Illinois Emergency 
Management Agency that the administration had occurred 3 years earlier. 
The Illinois Emergency Management Agency calculated an estimated dose 
to the fetus of 860 mSv (86 rem) and the fetal thyroid of over 
1,000,000 mSv (100,000 rem). A full-term child was subsequently born in 
August 2007 without a thyroid. The child was immediately placed on 
replacement hormone therapy and continues such treatment.
    Cause(s)--The cause of the event was found to be a combination of 
miscommunication and failure of the licensee to conduct an independent 
confirmatory pregnancy test.
Actions Taken To Prevent Recurrence
    Licensee--The licensee has subsequently made procedural changes to 
the interview process for screening patients for iodine-131 treatment. 
This policy includes a confirmatory negative pregnancy test. In 
addition, the licensee identified the significant delay in reporting 
the event to the Illinois Emergency Management Agency as not knowing 
the reporting requirement for this type of event.
    State--The Illinois Emergency Management Agency conducted an 
investigation of the event and issued a Notice of Violation (NOV) for 
the licensee's failure to report the event. The Illinois Emergency 
Management Agency is considering rulemaking to require the performance 
of testing to determine pregnancy prior to administration of iodine-
131.
AS10-02 Human Exposure to Radiation at Mercy Medical Center in Durango, 
Colorado
    Date and Place--March 16, 2010, Durango, Colorado.
    Nature and Probable Consequences--Mercy Medical Center (the 
licensee) reported that a therapeutic dose of 1,110 MBq (30 mCi) of 
iodine-131 for hyperthyroidism resulted in a dose to an embryo of 80 
mGy (8 rem) whole body. Prior to the treatment, the patient informed 
the licensee's staff that she was not pregnant and the licensee's staff 
administered a pregnancy test as a routine precaution. The pregnancy 
test yielded a negative result. Based on the negative pregnancy test 
results and the patient's interview responses, the licensee 
administered iodine-131 to the patient.
    On April 26, 2010, the patient performed a home pregnancy test that 
resulted in a positive test result. The patient's pregnancy was 
confirmed with a positive blood serum pregnancy test on April 27, 2010. 
The patient's OB/GYN estimated that conception

[[Page 38215]]

occurred on March 13, 2010 (about 1 week pregnant at the time of 
administration). A consulting medical physicist reviewed the case and 
estimated the embryonic exposure (whole body) at 53 to 92 mGy (5.3 to 
9.2 rem). The possibility of embryonic thyroid exposure was also 
investigated and determined to be insignificant due to the early stage 
of embryonic development. At this dose and administration time in 
relation to the embryonic development (blastogenesis), the licensee 
determined that no adverse impact will be likely on subsequent 
embryonic or fetal development and that subsequent health risks were 
unlikely. The patient was informed of the dose estimates and potential 
risks and she elected to continue the pregnancy.
    Cause(s)--The cause of this event was the close proximity of 
conception, which resulted in a negative pregnancy test, to the 
administration of the iodine-131.
Actions Taken To Prevent Recurrence
    Licensee--To help prevent recurrence, the licensee added additional 
questions to the screening process to help identify patients that might 
be pregnant even though all procedures to prevent this occurrence were 
followed.
    State--The State conducted an investigation and concurs with the 
licensee that a reasonable standard of care was met and, consequently, 
no enforcement action is warranted.
NRC10-01 Human Exposure to Radiation at Tripler Army Medical Center in 
Honolulu, Hawaii
    Date and Place--June 7, 2010, Honolulu, Hawaii.
    Nature and Probable Consequences--Tripler Army Medical Center 
(TAMC) (the licensee) reported that a female patient underwent a 
therapeutic administration of iodine-131 for thyroid ablation therapy. 
Prior to the treatment, the patient informed the licensee's staff that 
she was not pregnant and the licensee's staff administered a pregnancy 
test as a routine precaution. The pregnancy test yielded a negative 
result. Based on the negative pregnancy test results and the patient's 
interview responses, the licensee administered iodine-131 to the 
patient.
    On July 8, 2010, the patient became aware that she was pregnant and 
informed the licensee and her physician. On August 3, 2010, an 
ultrasound was performed on the patient and a determination was made 
that the actual date of conception was June 1, 2010 (about 1 week 
pregnant at time of administration). The TAMC radiation safety officer 
(RSO) estimated the embryonic dose to be 41.27 cGy (41.27 rad) and 
concluded that the exposure of the embryo in the first 2 weeks 
following conception is not likely to result in malformation or embryo/
fetal death despite the fact that the central nervous system and the 
heart are beginning to develop in the third week. The NRC contracted 
with a medical consultant to perform an independent medical evaluation 
of this embryo/fetal overexposure event. The consultant's report agreed 
with the TAMC conclusions with the exception that the medical 
consultant did not want to rule out the chance of embryo/fetal 
malformation.
    Cause(s)--The cause of this event was the close proximity of 
conception, which resulted in a negative pregnancy test, to the 
administration of the iodine-131.
Actions Taken To Prevent Recurrence
    Licensee--The patient consent form has been updated to reflect that 
the pregnancy test may not show a positive result until the embryo has 
implanted, which may not occur until 7-10 days after conception. In 
future consultations, the clinic plans to ask the patient to refrain 
from any action that may lead to pregnancy during the period 
immediately prior to therapeutic radioisotope administration.
    NRC--The NRC conducted an inspection on October 13-14, 2010, and 
concluded there were no violations of NRC requirements associated with 
this event.

II. Commercial Nuclear Power Plant Licensees

    During this reporting period, no events at commercial nuclear power 
plants in the United States were significant enough to be reported as 
AOs.

III. Events at Facilities Other Than Nuclear Power Plants and All 
Transportation Events

C. Medical Licensees

    During this reporting period, seven events at NRC-licensed or 
regulated facilities and five events at Agreement State-licensed 
facilities were significant enough to be reported as AOs.
AS10-03 Medical Event at Mercy St. Vincent Medical Center in Toledo, 
Ohio
    Date and Place--November 8, 2005 (reported on March 3, 2010), 
Toledo, Ohio.
    Nature and Probable Consequences--Mercy St. Vincent Medical Center 
(the licensee) reported that a medical event occurred associated with a 
brachytherapy seed implant procedure to treat prostate cancer. The 
patient was prescribed to receive a total dose of 160 Gy (16,000 rad) 
to the prostate using 67 iodine-125 seeds. Instead, the patient's 
sigmoid colon received at least the full prescription dose of 160 Gy 
(16,000 rad) and a significant portion of the bladder base including 
the region of the urethral orifices received at least 108 Gy (10,800 
rad) (wrong treatment sites). The patient and referring physician were 
informed of this event.
    On March 3, 2010, the Ohio Department of Health (ODH) performed an 
inspection of the licensee and noted that the licensee had not reported 
this medical event to the State and the NRC. The licensee had not 
identified the medical event as a reportable event and did not 
investigate it to determine a cause. Subsequently, the licensee 
reported the medical event to the NRC. The licensee confirmed that 13 
of the permanent iodine-125 seeds were improperly positioned in the 
bladder and subsequently removed from the patient's bladder immediately 
after the procedure. A post-implant dose calculation showed that the 
prostate received a dose of 15.43 Gy (1,543 rad), or 9.6 percent of the 
prescribed dose. The patient chose to then receive an external beam 
treatment with a linear accelerator to treat the tumor. About 13 months 
after the brachytherapy procedure, the patient developed rectosigmoid 
bleeding that required hospitalization and argon laser coagulopathy. In 
August 2010, ODH ordered an independent medical expert evaluation of 
the event. The independent medical expert concluded that the subsequent 
delivery of external beam radiotherapy may have contributed to the 
rectosigmoid damage, but the high dose from the brachytherapy procedure 
almost certainly was the primary cause of the damage.
    Cause(s)--The cause of the medical event was the failure of the 
licensee to adequately visualize the prostate prior to the implant 
procedure.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions taken by the licensee included 
training of the RSO, medical physicist, clinical director, and 
radiation oncologists on ODH regulations concerning medical events. New 
procedures were also developed for brachytherapy seed implant 
procedures.
    State--In March 2010, ODH conducted a special inspection of the 
licensee and issued an NOV. The NOV required the licensee to perform a 
self

[[Page 38216]]

audit of all brachytherapy cases performed since November 2004, which 
revealed seven additional medical events that were not reported. In 
June 2010, an Adjudication Order and administrative penalty of $25,000 
were issued to the licensee.
NRC10-02 Medical Event at Chippenham & Johnston-Willis Medical Center 
in Richmond, Virginia
    Date and Place--December 16, 2008, Richmond, Virginia.
    Nature and Probable Consequences--Chippenham & Johnston-Willis 
(CJW) Medical Center (the licensee) reported a medical event with its 
gamma stereotactic radiosurgery (GSR) unit. A patient being treated for 
trigeminal neuralgia (inflammation of the nerve) was prescribed a 
treatment of 40 Gy (4,000 rad) to the right trigeminal nerve but 
received the treatment dose to the left trigeminal nerve (wrong 
treatment site). The patient and referring physician were informed of 
this event.
    The licensee noted that on the day of the treatment, the top 
portion of the written directive correctly documented the prescribed 
treatment site; however, while the staff was preparing the daily 
patient treatment log, it was inadvertently annotated that the dose was 
to be delivered to the left trigeminal nerve. This error was carried 
through by the medical physicist during preparation of the patient's 
treatment plan and completion of the bottom part of the written 
directive. Upon completion of the procedure and after reviewing the 
patient's file, the treatment team identified the inadvertent treatment 
of the left trigeminal nerve. The NRC contracted medical consultant 
concluded that although no actual consequences resulted, an unlikely 
injury to the brain stem was possible due to high radiation dose to a 
tiny volume of the brain stem tissue and an increased risk of cataract 
formation.
    Cause(s)--The cause of the medical event was the licensee's failure 
to have adequate procedures that verify the location of treatment sites 
and ensure that any inconsistencies in the written directives are 
resolved prior to administration.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised their GSR treatment procedures to 
affirm that (1) a ``Physician Order'' will be the primary source of 
documentation of the treatment site and will accompany the patient 
through the entire course of the treatment, (2) the radiation 
oncologist and the neurosurgeon will independently verify and document 
the treatment site, (3) the nurse and the medical physicist will 
confirm that the treatment site identified by the radiation oncologist 
in the written directive and the neurosurgeon's ``physician order'' 
both match, (4) the neurosurgeon will mark the treatment site with ink 
in the presence of a nurse, and (5) a ``Time-Out'' process involving 
independent verification of the final treatment plan by each of the 
four members of the clinical team (who are required to sign-off their 
presence and acceptance of time-out in the presence of the patient 
before moving ahead with the treatment) will be used with the patient 
or the patient's authorized representative to confirm the treatment 
site.
    NRC--The NRC initiated an inspection on December 18, 2008. The NRC 
completed the inspection on November 30, 2009, and issued one Severity 
Level III violation to the licensee on January 21, 2010.
NRC10-03 Medical Event at Virtua Health System in Marlton, New Jersey
    Date and Place--January 19, 2009, Marlton, New Jersey.
    Nature and Probable Consequences--Virtua Health System (the 
licensee) reported that a medical event occurred associated with a 
brachytherapy seed implant procedure to treat prostate cancer. The 
patient was prescribed to receive a total dose of 145 Gy (14,500 rad) 
to the prostate using 93 iodine-125 seeds. Instead, the patient 
received an approximate dose of 12.2 Gy (1,220 rad) to the rectum 
(wrong treatment site). The patient and referring physician were 
informed of this event.
    On January 19, 2009, the urologist inserted needles in the 
patient's prostate gland under transrectal ultrasound guidance while 
the radiation oncologist left the operating room to obtain the 
radioactive seeds. The licensee's staff (including the authorized 
medical physicist [AMP]) questioned the accuracy of prostate 
visualization prior to implantation of the seeds but took no action to 
resolve the question. On February 23, 2009, following a post-implant 
computed tomography (CT) scan, it was noted that some mispositioning of 
the sources occurred and the patient was notified that additional 
treatment may be necessary. On March 19, 2009, the AMP reviewed the 
case and determined that 100 percent of the seeds were implanted 
outside of the prostate, which received about 10 Gy (1,000 rad). The 
NRC contracted with a medical consultant who concluded that although 
the probability of long-lasting negative health effects to the patient 
is low, an increased risk of impotency and fibrosis was possible due to 
the high radiation dose.
    Cause(s)--The cause of the medical event was failure of the medical 
implant team to adequately visualize and identify the prostate prior to 
the implant.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised its policy and procedures to require 
that (1) all members of the implant team be present before the patient 
is brought to the operating room and placed under anesthesia, (2) the 
AMP be included in the pre-implantation ultrasound, (3) the authorized 
user consult with the urologist before needle insertion, (4) both the 
radiation oncologist and the urologist agree on the positioning and the 
visualizing of the target anatomy, (5) any objection or question by an 
implant team member is cause for stopping the implant and performing a 
review, and 6) the implant be stopped if there are any ultrasound image 
questions. The licensee's staff was also trained on the revised 
procedures, the definition and reporting requirements of a medical 
event, and the communication of any CT scan abnormalities or seed 
misplacement to the RSO.
    NRC--The NRC initiated an inspection on March 20, 2009. The NRC 
completed the inspection on August 26, 2009, and issued one Severity 
Level III violation to the licensee on October 21, 2009.
NRC10-04 Medical Event at Nanticoke Memorial Hospital, Seaford, 
Delaware
    Date and Place--March 5, 2009 (reported on July 15, 2009), Seaford, 
Delaware.
    Nature and Probable Consequences--Nanticoke Memorial Hospital (the 
licensee) reported that a medical event occurred involving a 
brachytherapy seed implant procedure to treat prostate cancer. The 
patient was prescribed a total dose of 145 Gy (14,500 rad) to the 
prostate using 61 iodine-125 seeds. Instead, the patient received an 
approximate prostate dose of 26 Gy (2,600 rad) (18 percent of the 
prescribed dose) and a dose of 139 Gy (13,900 rad) to unintended tissue 
(wrong treatment site). The patient and referring physician were 
informed of this event.
    The seeds were implanted under ultrasound guidance using an axial 
view; however, following the implant, the urologist performed a 
cystoscopy to remove 22 of the seeds from the bladder. When the patient 
returned to the hospital for a post-implant CT scan, the images 
revealed that 32 seeds were displaced superiorly to the prostate and 7 
seeds were implanted in the prostate.

[[Page 38217]]

The NRC contracted with a medical consultant who concluded that no 
significant adverse health effects to the patient were expected.
    Cause(s)--The cause of the medical event was due to a 
miscalculation of the prostate depth in relation to the skin surface 
due to possible patient movement during the procedure.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised its prostate implant procedure to 
include the use of both the axial and sagittal views of an ultrasound 
probe to determine prostate depth. In addition, the licensee revised 
its medical event policy to ensure timely reporting of medical events 
and to clearly state the parameters under which a medical event must be 
reported. The licensee provided training on the revised policies and 
procedures to its staff.
    NRC--The NRC initiated an inspection on July 19, 2009. The NRC 
completed the inspection on January 6, 2010, and issued one Severity 
Level III violation to the licensee on February 2, 2010.
AS10-04 Medical Event at Hoag Memorial Hospital Presbyterian in Newport 
Beach, California
    Date and Place--March 20, 2009, Newport Beach, California.
    Nature and Probable Consequences--Hoag Memorial Hospital 
Presbyterian (the licensee) reported that a medical event occurred 
associated with its GSR unit. A patient being treated for an acoustic 
neuroma was scheduled to receive between 11 and 18 Gy (1,100 and 1,800 
rads) to an intended neuroma volume of 0.08 cm\3\ but, due to an 
unintended shift in the treatment volume of about 2 mm, only about one-
half of the neuroma received the treatment dose and an adjacent 
temporal bone volume of 0.04 cm\3\ received the treatment dose (wrong 
treatment site). The other half of the neuroma received between 3 and 
11 Gy (300 and 1,100 rads). The patient and physician were informed of 
this event.
    The unintended shift in treatment volume occurred due to a 
misaligned fiduciary marker (indicator) box during a CT scan used in 
the treatment planning process. The misalignment occurred because one 
alignment pin of four on the indicator box was not fully seated in the 
stereotactic frame attached to the patient's head, resulting in the 
indicator box not being correctly aligned. The alignment pin error was 
not detected until the conclusion of the treatment. The additional dose 
to the temporal bone because of the alignment error is not expected to 
result in any significant adverse health effect to the patient.
    Cause(s)--The medical event is believed to have been caused by 
human error in not ensuring the CT indicator box was properly installed 
at the time of the CT scan. It is not known if the improper 
installation occurred when the technologist positioned the indicator 
box in the stereotactic frame or whether the indicator box became 
misaligned during patient positioning in preparation for the CT scan.
Actions Taken To Prevent Recurrence
    Licensee--The licensee has retrained all CT technologists 
concerning the proper placement of the CT indicator box. Also, because 
use of CT imaging for GSR treatment is infrequent (normally MRI is 
used), the licensee now requires that a GSR qualified medical physicist 
verify the placement of the CT indicator box immediately prior to all 
CT imaging that will be used for GSR treatment planning.
    State--On June 22, 2009, the California Department of Public Health 
(CDPH) issued an NOV related to this event. Subsequently, CDPH received 
dosimetry information which they used to interpret the event as not 
meeting the AO criteria; however, CDPH was not certain of this 
determination and asked the NRC for a final determination. On July 1, 
2010, after the NRC Medical Radiation Safety Team (MSRT) had performed 
a careful analysis of the event along with the dosimetry data, the NRC 
determined that the event met the AO criteria.
AS10-05 Medical Event at Marshfield Clinic in Marshfield, Wisconsin
    Date and Place--June 2005 to May 2007, (reported on July 8, 2010) 
Marshfield, Wisconsin.
    Nature and Probable Consequences--In July 2010, the Marshfield 
Clinic (the licensee) reviewed all prostate brachytherapy cases 
performed under its license in the past 7 years. The review resulted in 
the identification of nine medical events involving permanent implants 
of iodine-125 for prostate brachytherapy where the total dose delivered 
differed from the prescribed dose by 20 percent or more, or another 
organ received at least 50 percent more dose than intended. The three 
medical events involved planned doses to the prostate of 120 Gy (12,000 
rad), 160 Gy (16,000 rad), and 160 Gy (16,000 rad). The licensee 
assumes an identical planned dose to the urethra. However, these 
treatments resulted in actual doses to the urethra of 191.6 Gy (19,160 
rad), 258.1 Gy (25,810 rad), and 242.6 Gy (24,260 rad), which were 
overdoses of 59.7, 61.3, and 51.6 percent, respectively. The licensee 
notified the affected patients and referring physicians.
    The authorized user physicians had previously determined that 
patients would not suffer significant health effects for urethral doses 
below 400 Gy (40,000 rad). Because the urethra penetrates through the 
center of the prostate and the prostate itself is a small gland, a 
balance exists between reducing the dose to the urethra and delivering 
the prescribed dose to the prostate. The doses delivered to the 
patients in question were well within the 400 Gy (40,000 rad) urethral 
tolerance dose, and the licensee considered the treatments to be 
clinically acceptable.
    Cause(s)--The licensee suspects that the implants deviated from 
their intended tracks after insertion into the prostate, causing the 
seeds to be deposited closer to the urethra.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions included developing a procedure for 
ensuring that treatments were delivered in accordance with the written 
directive, planning treatments to D90 (minimum dose received by 90 
percent of CT-defined prostate volume) values of 100-110 percent, using 
the same written directive form at each site that performs 
brachytherapy, increasing ultrasound and fluoroscopy visualization 
during prostate implants and providing additional training to 
personnel.
    State--The Wisconsin Department of Health Services determined that 
Marshfield Clinic did not have a procedure for evaluating whether the 
dose delivered in a prostate brachytherapy treatment was in accordance 
with the written directive. In addition, the licensee did not have 
criteria for identifying a medical event for prostate brachytherapy. 
The licensee has been cited for several items of noncompliance.
NRC10-05 Medical Event at Yale New-Haven Hospital, New Haven, 
Connecticut
    Date and Place--August 5, 2009, New Haven, Connecticut.
    Nature and Probable Consequences--Yale New-Haven Hospital (the 
licensee) reported that a medical event occurred associated with its 
GSR unit. A patient being treated for brain metastases was prescribed 
18 Gy (1,800 rad). However, while treating a patient earlier in the 
day, an equipment malfunction occurred with the GSR unit that resulted 
in a positioning shift of the x-axis by 4.5 mm. The positioning shift 
in the x-axis

[[Page 38218]]

resulted in an underdose to the treatment site and an overdose to a 
wrong treatment site. The patient and physician were informed of this 
event.
    The malfunction occurred following the treatment of the first 
patient on August 5, 2009. The automatic positioning system (APS) 
malfunctioned and, after discussion with the GSR manufacturer, the 
position error codes were cleared by the AMP. A second patient was 
treated for multiple brain metastases later that day. The GSR service 
personnel noted on August 5, 2009, that the APS positioning was off by 
about 5 mm. After further evaluation, the manufacturer determined that 
a position shift (offset) occurred when licensee personnel accepted an 
error message concerning position deviation. The NRC contracted with a 
medical consultant who concluded that no clinically significant side 
effects from radiation damage to the wrong treatment sites would be 
expected.
    Cause(s)--The cause of the medical event was failure of licensee 
personnel to verify that the APS coordinates were in accordance with 
the written directive.
Actions Taken To Prevent Recurrence
    Licensee--The licensee issued a memorandum to all personnel 
involved in GSR treatments to require visual verification of the 
physical coordinates against the electronic coordinates before the 
start and at the end of each treatment run. The licensee also retrained 
all GSR personnel on the importance of fully understanding error 
conditions and reviewing unexpected errors with other staff involved in 
the treatment (e.g., radiation oncologist, AMP, etc.) prior to clearing 
any unexpected error.
    NRC--The NRC initiated an inspection on August 13, 2009. The NRC 
completed the inspection on April 7, 2010, and issued one Severity 
Level III violation to the licensee on May 21, 2010.
NRC10-06 Medical Event at Valley Hospital in Paramus, New Jersey
    Date and Place--July 29, 2009, Paramus, New Jersey.
    Nature and Probable Consequences--Valley Hospital (the licensee) 
reported that a medical event occurred associated with a brachytherapy 
seed implant procedure to treat prostate cancer. The patient was 
prescribed a total dose of 65 Gy (6,500 rad) to the prostate using 46 
cesium-131 seeds. Instead, the licensee determined that an unintended 
volume (30.1 ml) of soft tissue received 100 percent of the prescribed 
prostate dose. The patient and referring physician were informed of 
this event.
    On August 6, 2009, the patient returned to the hospital for a post-
implant CT scan. The images revealed that the seeds were implanted in 
soft tissue 4 to 5 cm from the prostate. Post-implant dosimetry 
calculations indicated that none of the prostate received the 
prescribed dose of 6,500 cGy (6,500 rad). The NRC contracted with a 
medical consultant who concluded that the additional dose can increase 
the risk of soft tissue fibrosis or increase the risk of impotency.
    Cause(s)--The cause of the medical event was the licensee's failure 
to identify the position of the prostate due to the patient's unusual 
anatomy and obesity.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised their prostate implant procedures to 
include steps to ensure that the prostate and surrounding anatomy is 
adequately visualized prior to implant.
    NRC--The NRC initiated an inspection on August 13, 2009. The NRC 
completed the inspection on October 29, 2009, and determined that no 
violations of NRC requirements occurred.
NRC10-07 Medical Event at Christiana Care Health Center in Wilmington, 
Delaware
    Date and Place--January 18, 2010, Wilmington, Delaware.
    Nature and Probable Consequences--Christiana Care Heath Center (the 
licensee) reported that a patient was prescribed a high dose-rate (HDR) 
mammosite (brachytherapy) multi-lumen catheter treatment of 34 Gy 
(3,400 rad) over a 5-day period to the left breast. The patient 
received an average dose of 17 Gy (1,700 rad) to 100 cm\3\ of 
unintended breast tissue; 68 Gy (6,800 rad) to 7.5 cm\3\ of unintended 
skin and underlying tissue; and 3.4 Gy (340 rad) to 35 cm\3\ of 
intended breast tissue. The patient and referring physician were 
informed of this event.
    On February 22, 2010, during a follow-up examination, the patient 
complained about skin reddening on the external breast. In reviewing 
the treatment plan, it was discovered that the AMP performed 
measurements using a source position simulator (SPS) measurement tool 
following a CT scan to determine the treatment distance for each 
catheter. The catheter distances were recorded and confirmed with two 
manufacturer representatives that were present at the time of the 
treatment. However, it was noted that an incorrect measurement caused 
the placement of the radioactive source 10 cm proximal to the intended 
position. The NRC contracted medical consultant concluded that the dose 
that was administered to the unintended left breast tissue is unlikely 
to result in any significant or unusual adverse effect. However, a 
significant risk exists that local tumor recurrence could occur if 
additional intervention is not performed.
    Cause(s)--The cause of the medical event was human error in the 
failure to identify that the measurement tool was functioning 
improperly and to identify an incorrect measurement distance.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised its procedures for HDR brachytherapy 
to require a double-check of all patient measurements, a daily and 
monthly quality assurance requirement to confirm that the SPS tool is 
functioning properly, and a process to ensure that all members of the 
treatment team agree on the specifics of the treatment. In addition, 
the licensee acquired a new SPS tool, developed and posted a reference 
table at the HDR control console, provided training on revised 
procedures to staff involved in the HDR program (to be repeated 
annually), and implemented a ``New Product'' committee to review all 
new product plans.
    NRC--The NRC conducted an inspection on July 12, 2010, and issued 
one Severity Level III violation to the licensee on August 24, 2010.
AS10-06 Medical Event at Mary Bird Perkins Cancer Center in Baton 
Rouge, Louisiana
    Date and Place--March 15, 2010, Baton Rouge, Louisiana.
    Nature and Probable Consequences--Mary Bird Perkins Cancer Center 
(the licensee) reported that a medical event occurred associated with a 
brachytherapy seed implant procedure to treat prostate cancer. The 
patient was prescribed a total dose of 145 Gy (14,500 rad) to the 
prostate using iodine-125 seeds. Instead, the patient received a dose 
of 39.55 Gy (3,955 rad) to the rectum, 40.94 Gy (4,094 rad) to the 
urethra, and 6 Gy (600 rad) to the bladder (wrong treatment sites). The 
patient and referring physician were informed of this event.
    During the review of this event, the licensee determined that a 
positioning error occurred and the dose was delivered about 3.0 cm away 
from the targeted prostate gland. The estimated dose to the prostate 
gland was 12.88 Gy (1,288 rad). The licensee concluded that

[[Page 38219]]

no significant adverse health effect to the patient is expected.
Actions Taken To Prevent Recurrence
    Licensee--The licensee modified its procedure to insert the needles 
that hold the prostate in place prior to obtaining the ultrasound 
images instead of immediately before the seed needles are inserted. In 
addition, the sagittal image will be captured at the time of planning 
image acquisition and confirmed periodically throughout the case, and 
the radiation oncologist will personally confirm the location of the 
reference base prior to dispensing the first seed.
    State--The Louisiana Department of Environmental Quality conducted 
an investigation, reviewed the licensee's corrective actions, and found 
the corrective actions to be adequate.
AS10-07 Medical Event at Mayo Clinic in Rochester, Minnesota
    Date and Place--March 23, 2010, Rochester, Minnesota.
    Nature and Probable Consequences--The Mayo Clinic (the licensee) 
reported a medical event associated with an HDR biliary treatment for 
liver carcinoma containing 329 GBq (8.9 Ci) of iridium-192. A patient 
was prescribed to receive four fractionated doses totaling 16 Gy (1,600 
rad) to the liver. The treatment to the liver should have produced an 
estimated dose to the duodenum (wrong treatment site) of 1.2 Gy (120 
rad) but as a result of the event it received a dose of about 10 Gy 
(1,000 rad). The patient and referring physician were informed of this 
event.
    During the second fractioned treatment, the measurement cable was 
inserted into the catheter and it was noted that it extended about 17 
cm beyond the programmed treatment distance used during the first 
fractioned treatment. It was concluded that the measurement wire on the 
first treatment had met with some resistance at a tight bend and that 
it was not at the end of the catheter. This resulted in overdosing the 
duodenum (wrong treatment site). Upon discovery of the treatment 
distance error and overdose, the licensee changed the written directive 
to add a fifth fractioned treatment to correct for the underdose of the 
liver. A lesser total dose to the liver was given because of concerns 
regarding the dose already received by the duodenum. The authorized 
user concluded that no chronic health effect to the patient is 
expected.
    Cause(s)--The medical event was caused by human error in failing to 
verify that the correct catheter length was entered into the HDR unit.
Actions Taken To Prevent Recurrence
    Licensee--The licensee committed to taking several corrective 
actions including the imaging of inserted catheters prior to treatments 
and performing catheter length checks prior to HDR treatments.
    State--On April 6, 2010, the Minnesota Department of Health (MDH) 
staff performed a reactive inspection of the licensee's HDR program. 
The MDH approved the licensee's corrective actions and did not take 
enforcement action.
NRC10-08 Medical Event at Providence Hospital in Novi, Michigan
    Date and Place--August 30, 2010, Novi, Michigan.
    Nature and Probable Consequences--Providence Hospital (the 
licensee) reported that a medical event occurred associated with an 
anal brachytherapy treatment using 32 seeds containing iodine-125. The 
intended dose was 90 Gy (9,000 rad) to the tumor. Instead, the 
patient's seminal vesicle received 19.79 Gy (1,979 rad) more than 
intended and the bladder received 3.68 Gy (368 rad) more than intended. 
The patient and referring physician were informed of this event.
    On September 1, 2010, a follow-up CT scan showed that the permanent 
implants had been inserted about 4 cm from the intended location. The 
licensee reported that the tumor near the anus and rectum received a 
maximum dose of 8 Gy (800 rad). The licensee calculated the dose 
difference to the surrounding tissue as a result of the improper 
permanent implant placement. The licensee concluded that no significant 
adverse health effect to the patient is expected.
    Cause(s)--The licensee determined that the cause of the event was 
that they did not use tissue markers to confirm source placement and 
the insertion needle did not have a visible mark to ensure proper depth 
placement.
Actions Taken To Prevent Recurrence
    Licensee--Procedures were modified to administer sources as 
prescribed in the written directive as follows: (1) Any interstitial 
procedure that requires the use of fluoroscopy alone will be done with 
the use of tissue markers to confirm source placement, and (2) 
interstitial procedures that use fluoroscopy alone will have needle 
depth verified. The licensee completed training of licensee staff on 
the event and the corrective actions by October 1, 2010.
    NRC--The NRC's Region III staff reviewed and concurred on the 
licensee's corrective actions. The NRC has retained the services of an 
independent medical consultant to determine if any significant health 
effects to the patient are expected.

    Dated at Rockville, Maryland, this 23rd day of June, 2011.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 2011-16266 Filed 6-28-11; 8:45 am]
BILLING CODE 7590-01-P