[Federal Register Volume 59, Number 81 (Thursday, April 28, 1994)] [Unknown Section] [Page ] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-10123] [Federal Register: April 28, 1994] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION Abnormal Occurrences for Fourth Quarter CY 1993 Dissemination of Information Section 208 of the Energy Reorganization Act of 1974, as amended, requires NRC to disseminate information on abnormal occurrences (i.e., unscheduled incidents or events that the Commission determines are significant from the standpoint of public health and safety). During the fourth quarter of CY 1993, the following incidents at NRC licensees were determined to be abnormal occurrences (AOs) and are described below, together with the remedial actions taken. The events are also being included in NUREG-0090, Vol. 16, No. 4, (``Report to Congress on Abnormal Occurrences: October-December 1993''). This report will be available at NRC's Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC 20555 about three weeks after the publication date of this Federal Register notice. Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.) 93-11 Medical Branchytherapy Misadministration at Washington University Medical School in St. Louis, Missouri One of the AO reporting guidelines notes that a therapeutic dose that results in any part of the body receiving unscheduled radiation can be considered an abnormal occurrence. Date and Place--January 7, 1993 and February 26, 1993; Washington University Medical School; St. Louis, Missouri. Nature and Probable Consequences--On January 7, 1993, a Nucletron Micro-Selectron low-dose-rate (LDR) remote afterloader unit ejected a radioactive source without being programmed to do so and without a guide tube and applicator attached to the channel. The unguided source lay at an approximate distance of 3 centimeters (cm) (1.2 inches [in] from the nearest skin surface for approximately 5 minutes. The licensee estimated that less than 0.1 centigray (cGy) (0.1 rad) of additional dose was delivered to the skin surface. On February 26, 1993, a very similar incident occurred at the same facility. The incident involved a different patient and the same remote afterloader unit. The device again ejected the same strength and type of radioactive source without being programmed to do so. However, in this case, the source lay near the patient's leg for approximately 60 to 75 minutes, at an approximate distance of 5 cm (2 in) from the nearest skin surface. The licensee estimated the additional dose to the patient's leg to be approximately 3.5 cGy (3.5 rad). In both cases, the treatment of each patient was completed on another LDR remote afterloader unit in another room of the medical center. Cause or Causes--After the first incident on January 7, 1993, a manufacturer service engineer, who studied the device malfunction, was unable to identify the cause of the failure during his repair visit. The licensee's staff subsequently tested the device for 20 hours without discovering the cause of the failure, and concluded that the device was acceptable for use. This decision was based on the fact that they could not reproduce the malfunction. The remote afterloader was put back into service. On February 26, 1993, the device failed again when a second unprogrammed source was ejected by the afterloader. After this incident, which resulted in the second misadministration, the manufacturer provided a different field engineer who correctly diagnosed the problem as a failure in an operational amplifier. A previous recommendation made by the manufacturer to store unused sources in the auxiliary storage safe, instead of the remote afterloader's mobile storage container, may have contributed to the incident. The second field engineer indicated that some of the safety features which prevent sources from being erroneously ejected were not in effect or were not monitored by the device for the unprogrammed channels containing the unused sources. Actions Taken To Prevent a Recurrence Licensee--The licensee informed the NRC that use of the two Micro- Selectron-LDR remote afterloader units will be discontinued and a new model LDR afterloader will be installed. NRC has also asked the licensee to address the manufacturer's recommendation for storing the sources and the removal of some of the safety features, and any resulting corrective actions. NRC--The vendor has now revised the device's operating software to monitor and generate error messages and audible alarms for unprogrammed (unused) channels. The NRC has sent a letter to the licensee identifying the two events as misadministrations and requesting that the licensee ensure the required notifications to the referring physicians and patients have been made. (Letter from Roy J. Caniano, Chief, Nuclear Materials Safety Branch, NRC Region III, to Robert J. Hickok, Assistant Vice President for Medical Affairs, Washington University Medical School, forwarding inspection reports No. 030-02271/ 93001, 030-31205/93001, 030-15101/93001, Docket No. 030/02271, 030- 31205 and 030/15101, License No. 24-00167-11, dated January 12, 1994.) During an NRC safety inspection conducted from November 15 to 18, 1993, the inspectors focused on these two incidents in addition to other inspection areas. The results of this inspection are still under review. 93-12 Medical Brachytherapy Misadministration at Mercy Hospital in Scranton, Pennsylvania One of the AO reporting guidelines notes that a therapeutic dose that results in any part of the body receiving unscheduled radiation can be considered an abnormal occurrence. Date and Place--October 15, 1993; Mercy Hospital; Scranton, Pennsylvania. Nature and Probable Consequences--On October 15, 1993, Mercy Hospital in Scranton, Pennsylvania, notified NRC Region I of a therapeutic misadministration involving a Nucletron Micro-Selectron high dose rate (HDR) remote afterloader which occurred at the facility on April 23, 1993. The licensee identified this misadministration during a review of the past treatment records. A patient was scheduled to receive brachytherapy treatment to the apex of her vagina in three fractions using a Nucletron Micro Selectron HDR remote afterloader. The prescribed dose was 500 centigray (cGy) (500 rad) for each fraction and the use of a ring applicator was specified. On April 13, 1993, the patient was administered the first fractional treatment. After an examination of the patient following the first treatment, the physician revised the written directive and prescribed a change from the ring applicator to a standard vaginal cylindrical applicator for the remaining two treatments. On April 23, 1993, during the administration of the second treatment, the therapist erroneously entered the catheter length of 920 millimeter (mm) (36.2 inch) into the treatment computer instead of the intended 992 mm (39.1 inch). The physician failed to identify this error during his review of the treatment parameters prior to the initiation of the treatment. As a result of this erroneous entry, a majority of the treatment dose was administered to an unintended region near the opening of the vagina, and the intended site received an underdose differing from the prescribed dose by more than 20 percent. The physician stated that no adverse clinical effects are expected as a result of the underdose to the target site because this treatment was intended to administer a booster radiation dose. The oncologist also stated that the patient is not expected to experience any adverse effects as a result of the 500 cGy (500 rad) overexposure to the wrong treatment site misadministration. The NRC medical consultant, in his report to Region I, also stated a similar opinion (that it is unlikely the patient will suffer any adverse effects from the misadministration). The third fraction of the treatment was administered to the patient on April 29, 1993, as prescribed. The referring physician and the patient have been notified. The licensee submitted a written report of the misadministration to NRC Region I on October 29, 1993. Cause or Causes--The therapist did not enter the correct catheter length during initial setup for the second treatment. The licensee followed established procedures; however, the procedure did not require verification of all parameters at the time of the second check prior to each treatment. Actions Taken to Prevent Occurrence Licensee--The licensee has instituted a requirement that a medical physicist also review the final treatment plan prior to initiating the treatment. The treatment parameters for all brachytherapy (HDR) treatments will be transferred electronically to the magnetic card directly from the simulator. The output of this card will be reviewed by the medical physicist and the oncologist before the initiation of the treatment. NRC--Region I conducted a special inspection at Mercy Hospital on October 19, 1993. Inspection Report No. 030-02983/93-001, issued November 5, 1993, identified two apparent violations: (1) Failure to require supervised individual to follow written quality management procedures (QMP) 10 CFR 35.25(a)(2); (2) Failure to include policies and procedures in the QMP to meet the objective that each administration is in accordance with the written directive 10 CFR 35.32(a) After receipt and review of the medical consultant's report, Region I issued a Notice of Violation to the licensee on February 9, 1994, classifying the two violations at Severity Level IV in accordance with the NRC Enforcement Policy. An NRC medical consultant has been retained to review this misadministration. The medical consultant's report was received by Region I on February 3, 1994. (The medical consultant's report is filed in Docket No. 030-02983 in the Region I Materials License Docket Room. Inspection Report No. 030-02983/93-001 issued November 5, 1993, and the February 9, 1994, Notice of Violation are in the PDR.) The medical consultant questioned the licensee concerning its identification of a radiation oncologist as the referring physician. After discussion with the NRC's medical consultant, the licensee identified the patient's physician as the primary referring physician and then agreed to notify the physician. Following a review of the medical consultant's report, Region I confirmed in a telephone conversation that the licensee had contacted the patient's physician regarding the misadministration. The licensee stated that both referring physicians have been notified of this misadministration. The radiation oncologist had discussed the misadministration with the patient on October 21, 1993. 93-13 Medical Brachytherapy Misadministration at Mountainside Hospital in Montclair, New Jersey One of the AO reporting guidelines notes that a therapeutic dose that results in any part of the body receiving unscheduled radiation can be considered an abnormal occurrence. Date and Place--July 1, 1993; Mountainside Hospital; Montclair, New Jersey. Nature and Probable Consequences--On December 1, 1993, during a routine inspection, NRC identified a therapeutic misadministration involving a high-dose-rate (HDR) remote afterloader, which occurred at Mountainside Hospital in Montclair, New Jersey, on July 1, 1993. NRC identified the misadministration while reviewing the licensee's Radiation Safety Committee (RSC) meeting minutes for 1993. On July 1, 1993, a patient was scheduled to receive the last of three brachytherapy treatments to the right mainstem bronchus. Each fraction was to deliver 750 centigray (cGy) (750 rad) to the target using a Nucletron Mitro-Selectron HDR remote afterloader and an intrabronchial catheter. During the July 1, 1993 treatment, the radiation oncologist mistakenly connected the catheter to the HDR afterloader with a 750 mm (29.5 inch) transfer tube instead of a short connector. This prevented the source from entering the intrabronchial catheter, and while delivering a negligible dose to the tumor, the face, the lenses of the eyes, the thyroid, and the whole body of the patient received unscheduled exposure. The source strength at the time of the incident was 161,000 megabecquerel (4.35 curie) of iridium-192 and the exposure time was 445.5 seconds. Following the reconstruction of the incident by the licensee, the surface does to the lens of the left eye was determined by the licensee to be 1.97 cGy (1.97 rad), the does to the chin (the closest surface of the body) was 4.56 cGy (4.56 rad), and the dose to the thyroid was 3.07 cGy (3.07 rad). The physician identified the error upon termination of the treatment and wrote a memorandum about the incident to the hospital's physicist and radiation safety officer (RSO). The physician mistakenly determined that the incident was not a misadministration, and so advised the RSO. The RSO, relying on the physician's judgment, did not notify NRC and filed the report in the RSC minutes folder. The radiation oncologist decided against making up the missed third fraction of therapy. On December 3, 1993, NRC notified the licensee by telephone that the event constituted a misadministration and the licensee notified the NRC Operations Center the same day. The licensee's written report of the misadministration, dated December 13, 1993, was received in the NRC Region I office on December 17, 1993. After review of the report, Region I called the licensee to determine if the referring physician and the patient were notified of the misadministration. The licensee forwarded a copy of a letter dated December 20, 1993, from the radiation oncologist to the referring physician confirming a December 6, 1993, telephone conversation in which the referring physician was informed of the misadministration. The letter indicated that the referring physician did not feel it would be in the patient's best interest to be notified of the misadministration. NRC contracted a medical consultant to determine the significance of the misadministration to the patient. The medical consultant's report was received by Region I on February 3, 1994. The consultant's calculations of doses to the lens of the left eye, the chin, and the thyroid of the patient agreed with the licensee's estimates, based on the strength of the source, the time of exposure and the distances of the source from the patient. The consultant concluded that the patient would not suffer any adverse effects from the misadministration. The medical consultant also determined that the oncologist failed to notify the patient of the misadministration because he did not fully understand the requirements of 10 CFR 35.33(a)(3). After discussions with the consultant, the referring physician agreed to inform the patient of the misadministration. Cause or Causes--An error by the attending physician in connecting the catheter to the HDR remote afterloader, and the failure of the console operator to recognize the faulty connection were the direct causes of the event. Both individuals relied on the treatment computer to indicate any problems with the therapy setup. The computer on a Nucletron HDR is not designed to alert the user to an incorrect connection of a longer transfer tube. In addition, the medical consultant's report indicates that the second individual observing the transfer tube connection during each treatment setup was a different console operator. Since the console operator in attendance during the third treatment had not been present during the prior treatments, he/she was unaware of the intended setup. Actions Taken to Prevent Occurrence Licensee--The licensee arranged for additional training by Nucletron on July 30, 1993. The training was attended by both HDR remote afterloader units authorized users and by three technologist- console operators. NRC--NRC is reviewing the licensee's December 17, 1993 misadministration report and the findings of the December 1, 1993 NRC inspection. An NRC medical consultant was retained to review the misadministration. The medical consultant's report dated February 1, 1994, was received by the NRC Region I office on February 3, 1994. (The medical consultant's report will be placed in the file for Docket No. 03-02470 located in the Region I Materials License Docket Room. An inspection report will be issued to the licensee by February 18, 1994, and will be available in the PDR.) In addition to the comment made in the above sections, the consultant indicated that if the licensee had required a medical physicist to be present during every setup and treatment as recommended in NRC Bulletin 93-01, it is likely that this misadministration would not have occurred. In the consultant's opinion, a medical physicist would have been more likely to have noticed the human error in the setup of the third HDR treatment. An enforcement conference has been scheduled. 94-14 Exposure to a Nursing Infant at Queen's Hospital in Honolulu, Hawaii One of the AO reporting guidelines notes that a moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission can be considered an abnormal occurrence. Date and Place--December 2, 1991; Queen's Medical Center; Honolulu, Hawaii. Nature and Probable Consequences--On October 25, 1993, during a routine safety inspection, a Region V inspector discovered an unreported unscheduled exposure to the thyroid of a 9-month-old nursing infant. On December 2, 1991, a patient was administered 0.56 megabecquerel (15 microcuries) of iodine-131 for a diagnostic scan. Although the patient noted on a hospital form that she was breastfeeding, the technologist failed to notice this notation until the patient returned for a scan the following day. The patient was informed of the oversight by the licensee and was instructed to stop breastfeeding. The authorized user and the referring physician were also notified on December 3, 1991. The licensee's Radiation Safety Officer calculated the infant's absorbed thyroid dose to be approximately 250 millisievert (mSv) (25 rem) based on information obtained during the uptake scan of the mother 6 hours after the administration. The NRC retained a medical consultant to evaluate the circumstances of this misadministration. The consultant estimated the dose to the infant's thyroid to be between 160 to 650 mSv (16 to 65 rem). The medical consultant concluded that the infant is not likely to experience any adverse effects as a result of this misadministration. Cause or Causes--Failure of a supervised technologist to adequately review the hospital form used to inform the hospital staff that a patient is pregnant or breastfeeding as he/she was instructed by the authorized user. Actions Taken to Prevent Recurrence Licensee--The screening procedure used to inform the hospital staff that a patient is pregnant or breastfeeding was incorporated into the clinical procedure manual. It was reviewed by each of the technologists, and it will be reviewed by all new technologists upon being hired. It will also be reviewed annually during a radiation safety training course. NRC--NRC conducted inspections on September 28 and October 25-27, 1993. The December 2, 1991 misadministration was noted and reviewed during these inspections. A number of violations were identified as a result of these inspections and escalated enforcement actions are being considered. An NRC medical consultant was also retained to review the case. 93-15 Medical Brachytherapy Misadministration at Good Samaritan Medical Center in Zanesville, Ohio One of the AO reporting guidelines notes that a therapeutic dose that results in any part of the body receiving unscheduled radiation can be considered an abnormal occurrence. Date and Place--November 10, 1993; Good Samaritan Hospital; Zanesville, Ohio. Nature and Probable Consequences--A patient was being treated for lung cancer. The treatment included performing an iridium-192 therapeutic implant. The prescribed treatment dose was 6000 rad to the patient's lung. On November 10, 1993, a catheter was surgically implanted in the patient. Iridium-192 seeds, contained in a ribbon, were inserted into the catheter. Following normal licensee procedure, the physicist requested that the attending nurse order a ``stat'' chest x-ray in order to verify source position. The ``stat'' radiograph was completed and two hours later upon review of the film, the seed positions could not be visualized. Two additional radiographs using different techniques were done. In the second radiograph, completed one hour later, the seeds were located in the patient's throat. The ribbon was removed and the physician successfully reinserted the ribbon to the proper location. Another radiograph was done to verify the source location. The treatment time was recalculated to deliver the total original intended dose and the treatment was completed without further difficulty. The sources were in the improper location for about three hours, delivering an estimated dose to the larynx area of about 282 centigray (282 rad). An NRC medical consultant evaluated the medical aspects of the brachytherapy misadministration and concluded that the dose to the larynx and surrounding area is not clinically significant. The physician verbally notified the patient of the misadministration following the successful reinsertion of the source ribbon. A written report was provided to the patient on November 15 1993. Cause or Causes--The immediate cause of the misadministration was an apparent crimp in the catheter which resulted in the seeds not being placed correctly. The seeds were blocked by the crimp at the level of the patient's larynx. An inexperienced radiation therapy technician implanted the source. During interviews, the physician stated that it would be difficult for an inexperienced person to know the difference between a properly seated ribbon and when ribbon insertion was impeded by a crimp in the catheter. Actions Taken To Prevent Recurrence Licensee--The licensee's plan for preventing recurrence of the misadministration included: (1) Formalizing the dosimetrist's ``rule of practice'' regarding comparison of the ribbon and catheter lengths prior to source implantation in order to ensure that the ribbon is properly seated; (2) Providing training to all radiation therapy technologists and each medical physicist in the new procedure; (3) Requiring that the authorized user physically implant source ribbons; (4) Requiring that each radiation therapy technologist receive hands on training and instruction in source implantation; and (5) Requiring that the ``stat'' post-insertion radiograph be hand carried to the prescribing physician for evaluation as soon as possible to determine proper source placement. NRC--A special safety inspection was conducted by NRC Region III on January 19, 1994 to review the circumstances surrounding this misadministration. An NRC medical consultant was also retained to review this case. Based on the results of the special inspection, NRC identified an apparent violation that is being considered for escalated enforcement action. (Letter from W.L. Axelson, Director, Division of Radiation Safety and Safeguards, NRC Region III, to Dan Sylvester, Vice President for Professional Services, Good Samaritan Hospital, forwarded inspection report No. 030-30954/94001, Docket No. 030-30954, License No. 34-16725-02, dated February 11, 1994.) 93-16 Medical Brachytherapy Misadministration at Marquette General Hospital in Marquette, Michigan One of the AO reporting guidelines notes that a therapeutic dose that results in any part of the body receiving unscheduled radiation can be considered an abnormal occurrence. Date and Place--November 17-19, 1993; Marquette General Hospital, Marquette, Michigan. Nature and Probable Consequences--On November 17, 1993, a patient was undergoing a brachytherapy procedure using cesium-137 sealed sources placed in a treatment device (catheter) inserted into the patient's uterus. When the catheter was removed on November 19, it was observed that it was too short to have been fully inserted into the uterine cavity. The three sources in the catheter had actually been in the patient's vagina instead of the uterus. The case was evaluated by an NRC medical consultant who concluded that the lower vagina received a radiation dose of 2,700 centigray (2,700 rad) when it would not have received a significant dose if the treatment had been performed as planned. The medical consultant concluded that the radiation doses to the vagina would not be expected to cause any acute or long term effects because the vaginal tissue is extraordinarily tolerant of radiation. This placement error did not result in additional exposure to other organs. The intended treatment area received about 50 percent of the intended dose. Subsequently, the patient received an additional dose to the uterus to complete the prescribed treatment. The licensee informed the patient of the treatment error. Cause or Causes--The hospital routinely uses two lengths of catheters for brachytherapy treatments, a shorter catheter for vaginal procedures and a longer one for uterine procedures. The medical physicist inadvertently placed the cesium-137 sources in the shorter (vaginal) catheter instead of the required long catheter for the uterin procedure prescribed. Actions Taken To Prevent a Recurrence Licensee--The hospital has revised its procedures to include added precautions for assuring the correct length catheter is used in each brachytherapy procedure. NRC--The NRC conducted a special inspection beginning November 29, 1993, to review the circumstances surrounding the misadministration. No violations of NRC regulations were identified, but the licensee was directed to review its Quality Management Program to determine what modifications were needed to prevent similar misadministrations in the future. The NRC also retained a medical consultant to evaluate this case. Dated at Rockville, MD, this 21st day of April 1994. For the Nuclear Regulatory Commission. John C. Hoyle, Assistant Secretary of the Commission. [FR Doc. 94-10123 Filed 4-26-94; 8:45 am] BILLING CODE 7590-01-M