NMSS Licensee Newsletter December 1999 – January 2000 (NUREG/BR-0117, No. 99-4)
New NRC Fuel Cycle Facility Inspection Program
In 1999, the U.S. Nuclear Regulatory Commission (NRC) started an initiative for substantially revising its regulatory oversight program for fuel cycle facilities. The facilities subject to the over- sight program include gaseous diffusion plants, highly enriched uranium fuel fabrication facilities, low-enriched uranium fuel fabrication facilities, and one uranium hexafluoride production facility. These facilities possess large quantities of materials that are potentially hazardous (i.e., radioactive, toxic, and/or flammable) to the workers, public, and environment. This initiative resulted from the staff's fundamental reviews of the NRC's fuel cycle facility regulatory program, with the objective of improving regulatory oversight processes.
The goals are to establish objective indications of acceptable and changing licensee performance; increase stakeholder confidence in the NRC; increase regulatory effectiveness and efficiency; and reduce unnecessary regulatory burden. In this regard, the staff is revising the fuel cycle facility oversight program to: 1) increase the risk/performance-based approach, focusing on the more significant risks at fuel cycle facilities; 2) establish more objective safety and safeguards performance indicators (PIs) with accompanying performance thresholds; and 3) adapt the NRC inspection program to reflect these new approaches. The PIs, together with inspection findings that provide risk and performance insights, are intended to provide objective and reliable bases to determine if fuel cycle facilities are safe and SNM is safeguarded, as well as provide early indications of declining performance. A licensee performance assessment process will integrate information from PIs and safety/safeguards inspection findings. This will facilitate clear and predictable regulatory decisions such as determining overall safety/ safeguards performance; identifying needed changes in Agency regulatory emphasis; and supporting Agency actions, including enforcement actions. Harmonizing changes in the inspection findings significance determination process, licensee performance assessment process, and regulatory action (including enforcement) process, are also being considered.
A task force consisting of two teams is evaluating and proposing oversight program revisions. The teams are an oversight program framework development team, consisting of branch chiefs from Headquarters and regions, which is responsible for fuel cycle facility oversight activities; and an inspection procedure writing team, consisting of fuel cycle facility inspectors representing Headquarters and regions, which will revise the inspection procedures to reflect the new approach. Relevant lessons learned from the NRC's ongoing improvement of the reactor oversight program are being used by the teams. Revision of the regulatory oversight program is being closely integrated with other Agency initiatives and involves frequent stakeholder interactions, through public meetings and workshops, to provide opportunities to exchange and explain information and receive feedback.
Three stakeholder-noticed public meetings were held during the last quarter of 1999. These noticed public meetings will continue in 2000. Monthly Stakeholder workshop public meetings are planned to begin in February 2000 to exchange views with stakeholders concerning revision, pilot testing, and full implementation of the revised oversight program. In 2000, revised oversight program stakeholder training will be provided immediately before beginning a pilot program, involving fuel cycle facilities, to evaluate the revised oversight program.
A description with details concerning the oversight program revision, as well as stakeholder views from transcribed public meetings, are provided on the NRC internet web page. SECY99188, entitled, "Evaluation and Proposed Revision of the Nuclear Fuel Cycle Facility Safety Inspection Program" is available on the NRC web page and summarizes plans for revising the inspection program.
(Contact: Walter Schwink, NMSS, 3014157253, e-mail: firstname.lastname@example.org )
Trojan Completes Reactor Vessel Removal, Shipment, and Burial
On Sunday, August 8, 1999, the Trojan nuclear power plant reactor vessel was successfully delivered to the U.S. Ecology site on the Hanford Reservation near Richland, Washington for burial. The shipment of the 907-metric-ton (1000-ton) Westinghouse reactor vessel took approximately 36 hours to travel the 432-kilometer (270-mile) journey up the Columbia River from the Trojan site north of Portland, Oregon. A specially built 73-meter-long (240-foot long) barge and two tug boats were used to transport the reactor vessel up the Columbia River through four sets of locks operated by the Army Corp of Engineers. U. S. Coast Guard vessels provided escort for the reactor vessel shipment. The overland portion of the journey was completed using a special trailer, built with 20 axles, with 320 wheels. The overland journey at Hanford from the Port of Benton dock to the U. S. Ecology burial site was 50 kilometers (30 miles), traveling at a speed of 9 kilometers per hour (5 mph).
The Trojan reactor vessel shipment was the first shipment in the U.S. of an intact reactor vessel containing the activated core internals. The Yankee Rowe power plant in Massachusetts had previously shipped its decommissioned reactor vessel to South Carolina, for burial, before the Trojan shipment; however, the highly radioactive core internals had been removed from the Yankee Rowe reactor vessel before shipment. The disposal of the Trojan reactor vessel and internals as a single package was estimated to save about 670 person millisieverts (67 person rem) of dose and over 40 radioactive shipments, compared with the disposal alternatives.
The reactor vessel inventory consisted of over 55.5 petabecquerels (1.5 million curies), with cobalt-60 being the predominant gamma-emitting isotope. The radioactivity was the result of neutron activation of the reactor vessel and internals during operations. In addition, the internal surfaces were contaminated with approximately 5.735 petabecquerels (155 curies) of radioactive material. Before removal of the reactor vessel from containment, low-density concrete was injected into the reactor vessel to fix the internal loose contamination. Several centimeters ( inches) of shielding were added to key areas of the reactor vessel to reduce dose rates below regulatory limits for shipment. The highest dose rates measured on contact with the reactor vessel near the nozzles were 1.75 millisieverts/hr (175 mR/hr). Measured dose rates on the barge in the areas easily accessible to the tug boat personnel were less than 10 microsieverts (1 mR/hr). The shielded reactor vessel external surfaces were free of contaminated material and had been painted. As an additional precaution the reactor vessel was shrink-wrapped in plastic.
The 1130-Mw Trojan nuclear power plant began commercial operation in May 1976. The plant operated for 16 years and shut down in November 1992. On January 4, 1993, Portland General Electric announced permanent cessation of operations. During the operation of the Trojan reactor, 83.5 billion kilowatt-hours were generated, enough to provide electricity to 400,000 average residential customers. The Trojan site has been undergoing active dismantlement over the past several years and plans to complete the clean-up of the site and terminate its 10 CFR Part 50 licensee by the end of 2002. By removing the reactor vessel from the Trojan site, 99.9 percent of the remaining radioactive material at the Trojan site was successfully removed, excluding the spent fuel, which will require special storage until a Federal repository is available.
Application to remove and ship the reactor vessel as an intact package was sent to the NRC on March 31, 1997. On October 29, 1998, the NRC approved the shipment. Ten major contractors were involved with the reactor vessel removal and shipment project, providing support for heavy lifts, land transportation, water transportation, vehicle inspections, package tie-down design, barge design, traffic control, and security. Fourteen Federal, State, and local agencies provided regulatory oversight and support during the transportation activities.
The project had to overcome several significant technical obstacles for approval. For example, the vessel and internals had to receive special approval from the State of Washington for disposal in a shallow land burial site. To achieve this, a detailed exposure-pathway analysis was performed. The transport package also had to receive special NRC and Department of Transportation approval, since it could not be tested to meet certain package specifications, such as various package drop tests. Finally, the shipment had to be approved by the Coast Guard for transport up the Columbia River.
(Contact: Rachel Carr, DNMS, RIV, 8172766552, e-mail: email@example.com )
The NRC Holds Public Informational Meeting on G.E. Vallecitos
The U.S. Nuclear Regulatory Commission (NRC) held a public meeting in Livermore, California, on October 20, 1999, to discuss the licensed activities at the G.E. Vallecitos facility located between Pleasanton and Livermore, California. The meeting was held as a result of several requests by public officials representing Alameda County and the City of Pleasanton.
The G.E. Vallecitos site has been engaged in research, development, testing, and post- irradiation examination of reactor fuel since the 1950s. This site also includes three permanently shut-down reactor facilities that were part of the early technology development programs for commercial nuclear power. In 1987, the American Society for Mechanical Engineers recognized one of the reactors, Vallecitos Boiling Water Reactor, which operated from 1957 to 1963, as a historical landmark. A small test reactor is still in operation at the site.
The meeting was facilitated by Dwight Chamberlain, Director of the Division of Nuclear Materials Safety, Region IV, and a professional meeting facilitator, Alinda Page, who is based in Seattle. A G.E. Vallecitos representative and members of the NRC staff from Headquarters and the Region IV office made presentations during the meeting. The major area of interest expressed by the public and local officials before the meeting centered on the safety of periodic shipments of irradiated nuclear fuel to the G.E. Vallecitos site. This topic was discussed in detail by Susan Shankman, Deputy Director of the NRC's Spent Fuel Project Office. A representative from the California State Highway Patrol was available and answered questions regarding irradiated fuel escort responsibilities within California. In addition to the irradiated fuel shipment and storage issues, other topics that were discussed included the status of license renewal of the G.E. Vallecitos Special Nuclear Materials License; the shut-down reactors; the NRC's inspection program for licensed activities; and other related topics. The meeting was attended by approximately 8090 members of the public, many of whom asked questions during the meeting. In addition, the meeting was covered by local television, cable stations, and newspaper reporters. Several of the interested local public officials or their representatives also took part in the discussions and questioning of the NRC. Overall, the NRC believed that this meeting was an effective outreach to interested stakeholders.
(Contact: Rachel Carr, DNMS, RIV, 8172766552, e-mail: firstname.lastname@example.org )
Loading of the First Three Mile Island Unit2 Fuel into Dry Storage at Idaho Independent Spent Fuel Storage Installation
On March 19, 1999, Special Nuclear Material License (SNM2508) was issued to the U.S. Department of Energy (DOE)Idaho, for the Three Mile Island Unit-2 (TMI2) Independent Spent Fuel Storage Installation (ISFSI). The ISFSI is licensed under 10 CFR Part 72. On March 31, 1999, the first cask containing TMI2 core debris was successfully loaded into a storage container at the ISFSI. The operation was conducted safely and in compliance with the license issued by the U.S. Nuclear Regulatory Commission (NRC).
The Energy Reorganization Act of 1974 requires the NRC to regulate DOE facilities primarily used for the receipt and storage of high-level wastes--including spent nuclear fuel--resulting from activities licensed under the Atomic Energy Act of 1954. Therefore, activities associated with the TMI2 fuel stored at the ISFSI fall under NRC regulation.
The ISFSI is located at the Idaho Nuclear Technology and Engineering Center (INTEC), at the Idaho National Engineering and Environmental Laboratory (INEEL). The facility is approximately 80 kilometers (50 miles) from the city of Idaho Falls, Idaho, and approximately 48 kilometers (30 miles) from the Test Area North (TAN) facility, where the TMI2 core debris is currently kept in wet storage. The dry cask storage system used is the Transnuclear West NUHOMS design, which includes concrete horizontal storage modules and ferric steel canisters. The TMI2 system, however, is unique, compared with other dry cask storage systems, in that the casks are vented through high-efficiency particulate air filters to the atmosphere, because of the off-gassing of hydrogen by the fuel debris.
The ISFSI is designed to store up to 344 TMI2 canisters. The ISFSI layout is based on the use of a maximum of 30 horizontal storage modules, each module holding a dry shielded canister (DSC), which in turn holds 12 individual TMI2 canisters. The ISFSI will store all TMI2 core debris received at INEEL.
The inspection of the TMI2 ISFSI was conducted over a 5-week period by an inspection team from Region IV, supplemented by personnel from NRC Headquarters. The NRC inspection team consisted of eight inspectors and included observation of the pre-operational testing and the actual loading of the first dry storage cask with TMI2 core debris. The inspection identified two violations, related to quality assurance oversight of activities by the contractors, before the turn-over of completed facilities, equipment, and systems to the DOE.
The activities associated with the TMI2 ISFSI project involved a large number of people, several contractors, numerous organizational groups, and oversight by several consultants, as well as the NRC inspection team. Despite the complexity of the organization responsible for the project, the NRC inspection team found the cooperation and working relationships, among all organizations involved with the project, to be excellent. The NRC inspection team observed a strong emphasis on safety and a conscientious attitude toward meeting the requirements of the NRC license and commitments made by the DOE in the Safety Analysis Report.
(Contact: Rachel Carr, DNMS, RIV, 8172766552, e-mail: email@example.com )
Change in the Leadership of the Organization of Agreement States
In 1959, Section 274 of the Atomic Energy Act was enacted to spell out a State role and to provide a statutory basis under which the Federal government could relinquish, to the States, portions of its regulatory authority. The 1959 amendments made it possible for the States to license and regulate byproduct materials (radioisotopes); source materials (uranium and thorium); and small quantities of special nuclear materials (radioactive materials capable of fission in large quantities). The mechanism for the transfer of the U.S. Nuclear Regulatory Commission's (NRC's) authority to a State is an agreement signed by the Governor of the State and the Chairman of the Commission. On March 26, 1962, the State of Kentucky became the first to sign such an agreement, thus becoming the first Agreement State.
Today, 31 States have entered into such Agreements with the NRC, and four others are currently being evaluated. In December 1964, the then U.S. Atomic Energy Commission hosted the first Annual Joint Meeting with a group of these States. Sometime later, State program directors came together to form the Organization of Agreement States (OAS). The Executive Committee is composed of a chairman, past-chairman, chairman-elect, secretary, and secretary-elect. The chairman is designated as the principal point of contact for the OAS.
As of January 1, 2000, Mr. Edgar Bailey, California's Radiation Control Program Director, began his term as Chairman of the OAS. He becomes the first repeat Chairman, having previously served in that capacity in 1986. Mr. Bailey is a graduate of the University of Texas, receiving both Bachelor of Engineering Science (Nuclear Power Option) and Master of Science in Environmental Health Engineering (Radiation Protection) degrees from that institution. He is a Registered Professional Engineer and a Certified Health Physicist. Mr. Bailey has managed the California program since 1989. The California Agreement State effort is the largest in the nation, with over 2100 radioactive materials licensees within its jurisdiction. Before moving to California, he was with the Texas Radiation Control Program for almost 20 years. In addition to his participation in the OAS, Mr. Bailey is a Member and Parliamentarian of the American Board of Health Physics, President of the Northern California Chapter of the Health Physics Society, and Chairman-Elect of the Government Section of the Health Physics Society.
The following is a complete listing of OAS Executive Committee members:
Edgar D. Bailey, CHP, Chief Chairman
Radiologic Health Branch
Food, Drugs & Radiation Safety Division
California State Department of Health Services
P. O. Box 942732
Sacramento, CA 942347320
Kathy Allen, Senior Project Manager
Office of Radiation Safety
Illinois Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
Stanley R. Marshall, Supervisor
Radiological Health Section
Bureau of Health Protection Services
Nevada State Health Division
1179 Fairview Drive, Suite 102
Carson City, NV 897015405
Phone: 7756875394, x276
Richard A. Ratliff, P.E., LMP, Chief Secretary
Bureau of Radiation Control
Texas Department of Health
1100 West 49th Street
Austin, TX 787563189
Alice Hamilton Rogers, PE, Section Manager
Underground Injection Control
Radioactive Waste Section
Texas Natural Resource Conservation Commission
P.O. Box 13087
Austin, TX 787113087
(Contact: Rosetta Virgilio, OSP, 3014152307, e-mail: firstname.lastname@example.org )
Generic Communications Issued (October 1, 1999 November 30, 1999)
Note that these are only summaries of U.S. Nuclear Regulatory Commission (NRC) generic communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical contacts listed below. For more information, see the NRC library of generic communications.
Regulatory Issue Summaries (RIS)
RIS 9901, "Revisions to the Generic Communications Program," was issued on October 4, 1999. This summary was issued to all NRC licensees to inform them of actions to improve the Agency's generic communications program. These actions include replacing administrative letters with new regulatory issue summaries, and requiring early interaction with senior NRC management and the industry on certain generic issues.
(Contacts: Eric J. Benner, NRR, 3014151171, e-mail: email@example.com ; Kevin M. Ramsey, NMSS, 3014157887, e-mail: firstname.lastname@example.org )
RIS 9904, "Sources of Information Previously Published in the AEOD Annual Report," was issued on November 23, 1999. This summary was issued to all NRC licensees to inform them that the annual report from the Office for the Analysis and Evaluation of Operational Data will no longer be published, and certain information can still be obtained from other sources.
(Contact: Jose G. Ibarra, RES, 3014156345, e-mail: email@example.com )
Information Notices (INs)
IN 9929, "Authorized Contents of Spent Fuel Casks," was issued on October 28, 1999. This notice was issued to all power reactor and spent fuel storage licensees to alert them to pay close attention to the authorized contents of spent fuel casks, especially when considering the loading of burnable poison rod assemblies and thimble-plugging devices.
(Contacts: Timothy J. Kobetz, NMSS, 3014158538, e-mail: firstname.lastname@example.org ; James J. Pearson, NMSS, 3014151985, e-mail: email@example.com )
IN 9930, "Failure of Double Contingency Based on Administrative Controls Involving Laboratory Sampling and Spectroscopic Analysis of Wet Uranium Waste," was issued on November 8, 1999. This notice was issued to all fuel cycle licensees and certificants, performing laboratory analysis to determine uranium content, to alert them to problems recently noted with the analysis of uranium- contaminated material. Under certain conditions, incomplete dissolution of samples may produce nonconservative results.
(Contact: Dennis C. Morey, NMSS, 3014156107, e-mail: firstname.lastname@example.org )
IN 9931, "Operational Controls to Guard Against Inadvertent Nuclear Criticality," was issued on November 17, 1999. This notice was issued to all fuel cycle conversion, enrichment, and fabrication licensees to alert them to a recent nuclear criticality accident at a foreign fuel fabrication facility. Licensees are encouraged to review their policies and procedures, and the results of safety assessments, to avoid similar problems.
(Contact: William Troskowski, NMSS, 3014158076, e-mail: email@example.com )
(General Contact: Kevin Ramsey, NMSS, 3014157887, e-mail: firstname.lastname@example.org )
Selected Federal Register Notices (October 1, 1999 - December 31, 1999)
NOTE: U.S. Nuclear Regulatory Commission (NRC) contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, DC 205550001.
"Changes, Tests, and Experiments Made without Prior NRC Approval," 64 FR 53582, October 4, 1999.
(Contact: Eileen McKenna, NRR, 3014152189, e-mail: email@example.com )
"Expand Applicability of Part 72 to Holders of, and Applicants for, Certificates of Compliance," 64 FR 56114, October 15, 1999.
(Contact: Anthony DiPalo, NMSS, 3014156191, e-mail: firstname.lastname@example.org )
"List of Approved Spent Fuel Storage Casks: (VSC24) Revision, Direct Final Rule: Delay of Effective Date," 64 FR 67700, December 3, 1999.
(Contact: Stan Turel, NMSS, 3014156234; e-mail: email@example.com )
"List of Approved Spent Fuel Storage Casks: (VSC24) Revision; Withdrawal of Direct Final Rule," 64 FR 72019, December 23, 1999.
(Contact: Stan Turel, NMSS, 3014156234; e-mail: firstname.lastname@example.org )
"Issuance, Availability of NUREG0713, `Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other Facilities,''' 64 FR 72704, December 28, 1999.
Contact: REIRS Project Manager, Mailstop T9F31, U.S. Nuclear Regulatory Commission, Washington, DC 205550001.
"Clarification and Addition of Flexibility for Part 72," 64 FR 59684, November 3, 1999.
(Contact: Anthony DiPalo, NMSS, 3014156191, e-mail: email@example.com )
"Revision of Management Directive for Review of 10 CFR 2.206 Petitions; Request for Comments," 64 FR 54654, October 7, 1999.
(Contact: Herbert N. Berkow, NRR, 3014151485, e-mail: firstname.lastname@example.org )
"Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders; Public Meeting," 64 FR 55176, October 12, 1999.
(Contact: Francis X. Cameron, OGC, 3014151642, e-mail: email@example.com )
"Issuance and Availability of Revision 1 of Regulatory Guide 8.15, Acceptable Programs for Respiratory Protection,'' 64 FR 55315, October 12, 1999.
"NRC Enforcement Policy; Enforcement Action Against Non-licensees under 10 CFR Part 72," 64 FR 56129.
(Contact: Richard W. Borchardt, OE, 3014152741, e-mail: firstname.lastname@example.org )
"Control of Release of Solid Materials at Licensed Facilities: Extension of Comment Period on Issues Paper," 64 FR 56274, October 19, 1999.
(Contact: Frank Cardile, NMSS, 3014156185, e-mail: email@example.com )
"Fissile Material Shipments and Exemptions; Response to Comments and Request for Information," 64 FR 57769, October 27, 1999.
(Contact: Naiem S. Tanious, NMSS, 3014156103, e-mail: firstname.lastname@example.org )
"Employee Protection Training; Receipt of Petition for Rulemaking from Union of Concerned Scientists," 64 FR 57785, October 27, 1999.
(Contact: David L. Meyer, Office of Administration, 3014157162 or toll-free: 18003685642)
"Selection of Sample Rate and Computer Wordlength in Digital Instrumentation and Control Systems, Availability of Draft NUREG1709 for Comment," 64 FR 58107, October 28, 1999.
(Contact: Terry Jackson, RES, 3014156486, e-mail: email@example.com )
"Petition From the State of Nevada; Extension of Comment Period," 64 FR 59684, November 3, 1999.
(Contact: James Smith, NMSS, 3014156459, or toll-free: 8003685642, e-mail: firstname.lastname@example.org )
"Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution, Availability of Draft NUREG1556," Vol. 12. 64 FR 60246, November 4, 1999.
(Contact: Sally L. Merchant, NMSS, 3014157874; e-mail: email@example.com )
"Revision of the NRC Enforcement Policy (NUREG1600)," 64 FR 61142, November 9, 1999.
(Contacts: Bill Borchardt, OE, 3014152741, e-mail: firstname.lastname@example.org ; Renee Pedersen, OE, 3014152742, e-mail: email@example.com )
Keith J. Schiager, Ph.D.; "Withdrawal of Petition for Rulemaking," 64 FR 65665, November 23, 1999.
(Contact: James A. Smith, NMSS, 3014156459, e-mail: firstname.lastname@example.org )
Envirocare of Utah, Inc.; "Withdrawal of Petition for Rulemaking," 64 FR 66115, November 24, 1999.
(Contact: Jayne M. McCausland, NMSS, 3014156219, e-mail: email@example.com )
"Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees," NUREG1556, Vol. 12, 64 FR 66214, November 24, 1999.
(Contact: Sally L. Merchant, NMSS, 3014157874; e-mail: firstname.lastname@example.org )
Office of Civilian Radioactive Waste Management, Nuclear Waste Repositories," Yucca Mountain Site Suitability Guidelines," Proposed Rulemaking, 64 FR 67054, November 30, 1999.
(Contact: Dr. William J. Boyle, U.S. Department of Energy, Office of Civilian Radioactive Waste Management, Yucca Mountain Site Characterization Office, P.O. Box 98608, Las Vegas, Nevada 891938608, toll-free: 8009673477)
"Decommissioning Criteria for the West Valley Demonstration Project (M32) and West Valley Site," Draft Policy Statement and Notice of Public Meeting, 64 FR 67952, December 3, 1999.
(Contact: Jack D. Parrott, NMSS, 3014156700, e-mail: email@example.com )
"Waste Confidence Decision Review: Status," 64 FR 68005, December 6, 1999.
(Contact: Janet Kotra, NMSS, 3014156674, e-mail: firstname.lastname@example.org )
"Supplemental Information on the Implementation of the Final Rule on Radiological Criteria for License Termination," 64 FR 68005, December 7, 1999.
(Contact: Boby Abu-Eid, NMSS, 3014155811, fax: 3014155398, or e-mail: email@example.com )
Availability of NUREG/BR0006, "Instructions for Completing Nuclear Material Transfer Reports,'' dated September 1999, 64 FR 69047, December 9, 1999.
(Contact: Lidia Roche, NMSS, 3014157830, e-mail: firstname.lastname@example.org )
Availability of Revision 3 of NUREG/BR0007, "Instructions for the Preparation and Distribution of Material Status Reports,'' dated December 9, 1999. 64 FR 69047, December 9, 1999.
(Contact: Lidia Roche, NMSS, 3014157830, e-mail: email@example.com )
Advance Notice of Proposed Rulemaking: "Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste," 64 FR 71331, December 21, 1999.
(Contacts: Tony DiPalo, NMSS, 3014156191, e-mail: firstname.lastname@example.org ; Stephanie R. Martz, OGC, 3014151520, e-mail: email@example.com )
(General Contact: Paul F. Goldberg, NMSS, 3014157842, e-mail: firstname.lastname@example.org)
Significant Enforcement Actions
Detailed information about these enforcement actions can be accessed via the U.S. Nuclear Regulatory Commission (NRC) homepage. Click on "Nuclear Materials," then "Enforcement," then "Enforcement Actions." Cases are listed alphabetically. To access the complete enforcement action, click on the highlighted text after the name of the case.
Richard W. Dungan, IA 99026. A Severity Level III violation was issued because the individual deliberately allowed an employee to use a gauge without completing the required training program and without dosimetry. The individual cooperated during the inspection and investigation, and was counseled and retrained by the company.
Allan A. Myers, Inc., Worcester, Pennsylvania, EA 99042. A $2750 civil penalty was assessed for deliberately allowing an employee to use a nuclear gauge without being properly trained or certified and without wearing appropriate dosimetry, and because the gauge was left unattended at the work site.
Bradley K. Sherwin, IA 99030. A Severity Level III violation was issued because Mr. Sherwin provided inaccurate information to the NRC and caused his employer to be in violation of NRC regulations by leaving a gauge unattended in an unrestricted area at a temporary jobsite.
Richard A. Speciale, IA 99019. An Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately) was issued on July 21, 1999. The Order prohibits involvement in NRC-licensed activities for 5 years, and requires notice to the NRC of any subsequent involvement for 5 years thereafter. The Order was issued because Mr. Speciale: (1) allowed untrained individuals to use moisture density gauges; (2) did not provide these individuals with dosimetry; (3) provided inaccurate information to the NRC; and (4) directed the use of gauges even though the license had been suspended.
Testing Engineers & Consultants, Inc., Troy, Michigan, EAs 99097 and 99169. Civil Penalties in the amount of $5500 were assessed based on deliberate failure to secure or control a nuclear gauge at a temporary jobsite and deliberate failure to provide complete and accurate information to NRC inspectors.
Triad Engineering, Inc., Morgantown, West Virginia, EA 99134. A Severity Level III violation was issued for failure to secure a gauge stored in the bed of a pick-up truck and stolen from a temporary jobsite. Credit was given for corrective action, and a civil penalty was not assessed, in accordance with the Enforcement Policy.
Gary Isakoff, IA 98006. An Order Prohibiting Involvement in NRC-Licensed Activities for 1 year and requiring notice to the NRC of any subsequent involvement for 1 additional year was issued February 24, 1999. The action was based on the conclusion that Mr. Isakoff deliberately falsified a weekly wipe test survey record; requested a subordinate technologist to falsely state that she had conducted the test; and prepared inaccurate dose-dispensing records. Mr. Isakoff requested a hearing on the Order. Subsequently, a settlement was reached in which the NRC agreed to withdraw the Order, and Mr. Isakoff agreed that he will not be involved in NRC-licensed activities for 1 year, beginning August 11, 1999, and will report any subsequent involvement to the NRC for 3 additional years.
North Country Hospital and Health Center, Inc., Newport, Vermont, EA 99153. A Notice of Violation for a Severity Level III problem was issued for violations associated with a misadministration, including failures to instruct and supervise the technologist; prepare a written directive; and report the misadministration--as well as failure of the RSO to investigate the misadministration. Credit was given for corrective action, and a civil penalty was not assessed, in accordance with the Enforcement Policy.
Saint Clare's Hospital, Dover, New Jersey, EA 99210. A Notice of Violation for a Severity Level III problem was issued after the loss of three iodine-125 brachytherapy seeds, which was not reported to the NRC as required. The loss was caused by failure to perform an adequate survey. Credit was given for corrective action and a civil penalty was not assessed, in accordance with the Enforcement Policy.
Envirocare of Utah, Inc., Salt Lake City, Utah, EA 99168. A violation was issued at Severity Level III, based on failure to perform adequate surveys in accordance with 10 CFR 20.1501. Credit was given for corrective action and a civil penalty was not assessed, in accordance with the Enforcement Policy.
Metorex, Inc., Ewing, New Jersey, EA 99043. A Notice of Violation was issued for a Severity Level III problem involving deliberate unauthorized transfer of x-ray fluorescence analyzer devices and deliberate failure to submit required quarterly reports of such transfers to the NRC. The violations were identified and reported to the NRC by the licensee's former President, and credit was given for corrective action; therefore a civil penalty was not assessed, in accordance with the Enforcement Policy.
Stanislaw Piorek, Ph.D., IA 99037. A Confirmatory Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately) was issued August 19, 1999, because Dr. Piorek deliberately failed to stop unauthorized shipments of x-ray fluorescence analyzer devices, and deliberately failed to submit quarterly reports to the NRC. The Order prohibits involvement in NRC-licensed activities for a period of 3 years, and requires notice to the NRC the first time he is involved, after the 3-year prohibition.
United States Enrichment Corporation (USEC), Bethesda, Maryland, EA 99080. A $55,000 civil penalty was assessed based on failure to classify, as an Alert, an emergency situation involving a fire, at USEC's Portsmouth plant, that could have led to a release of radioactive material.
Anvil Corporation, Bellingham, Washington, EA 99083. An $8800 civil penalty was assessed based on violations associated with a radiography incident, including personnel overexposures and failures to supervise a radiographer's assistant; perform an adequate survey; and wear an operating alarm ratemeter.
International Radiography and Inspection Services, Tulsa, Oklahoma, EAs 98565 and 99090. Civil penalties totaling $17,600 were assessed for deliberate violations, including failure to conduct radiation surveys and use personnel monitoring equipment, and resumption of radiography before assessing the radiation exposure involved when a pocket dosimeter was found to be off-scale. The licensee requested mitigation based on its thorough investigation and classification as a small business entity. A settlement was reached in which the licensee agreed to pay $13,200 in civil penalties.
(Contact: Joseph DelMedico, OE, 3014152739, e-mail: email@example.com )
Event 1: Fire Breaches Containment and Requires Shutdown of a Portion of the Cascade at the Portsmouth Gaseous Diffusion Plant in Piketon, Ohio
Date and Place—December 9, 1998; Portsmouth Gaseous Diffusion Plant, a uranium enrichment plant, operated by Lockheed Martin Utility Services for the United States Enrichment Corporation, located about 3.2 kilometers (2 miles) east of Piketon, Ohio.
Nature and Probable Consequences—On December 9, 1998, the certificate holder's operations staff observed a series of abnormal conditions associated with the side purge cascade, Cell 2572. The staff's immediate response to the abnormal conditions was not successful in restoring normal operations and an exothermic reaction was either started or propagated within the cascade. The exothermic reaction continued until sufficient heat was generated to cause a failure of the Cell 2572 cooling system, initiating a second exothermic reaction. Subsequent heat and pressure increases within the side purge cascade resulted in (1) the creation of holes within the process gas cascade boundary of Cell 2572; (2) an automatic shutdown of the side purge cascade; (3) the activation of a portion of the Building X326 automatic fire suppression sprinkler system; (4) an emergency response and approximately 2 hours of firefighting activities by the onsite fire department; and (5) challenges to the continued operation of the remainder of the process gas cascade.
The radiological and chemical consequences of the event for plant staff were minor and well within applicable U.S. Nuclear Regulatory Commission (NRC) requirements. The general public experienced no measurable radiological or chemical consequences from this event.
Cause or Causes—The extensive fire damage experienced by Cell 2572 equipment has made it difficult to determine the root cause. Much of the equipment has been damaged to such an extent that evidence needed to determine the root cause was destroyed. The investigation by the certificate holder identified two possible initiating events: a physical failure of the compressor impeller or a chemical deposit caused by wet air leakage into the equipment.
Actions Taken To Prevent Recurrence
Certificate Holder—The certificate holder is implementing short and long term corrective actions to prevent recurrence.
NRC—An augmented inspection team was sent to the site on December 9, 1998. The team documented its findings in an inspection report issued on February 19, 1999. A follow-up inspection was conducted in March 1999 to evaluate the effectiveness of the certificate holder's corrective actions. Although the follow-up inspection team found the certificate holder's corrective actions adequate, several procedural and reporting violations were identified during the follow-up inspections. One violation was that the event met the criteria for an "Alert" declaration and that the certificate holder failed to identify and declare the Alert. That failure led to escalated enforcement action—a Severity Level III violation that carried a $55,000 civil penalty. The certificate holder acknowledged the violation and paid the civil penalty.
Event 2: Medical Event Involving the Administration of Iodine-131 to a Pregnant Patient at St. Joseph Health Center in Kansas City, Missouri
Date and Place—October 6, 1998; St. Joseph Health Center; Kansas City, Missouri.
Nature and Probable Consequences—After a patient was administered a 5.75-gigabecquerel (155.2-millicurie) dosage of iodine-131 (I131) for ablation of residual thyroid tissue and for the treatment of metastatic thyroid cancer, it was learned that she was pregnant.
Preceding the administration of the I131 therapy dosage, the licensee's nuclear medicine technologist and the authorized user, following internal policies and procedures to determine the pregnancy status of a patient, repeatedly questioned the patient about the possibility of a pregnancy and whether she was breast-feeding. The patient stated that she was not breast-feeding and there was no possibility of pregnancy. Approximately 3-1/2 hours after the I131 administration, the licensee received the positive results of a pregnancy test previously ordered by the patient's referring physician. The licensee had not been aware that the referring physician had ordered the pregnancy test.
On notification of the pregnancy, the licensee told the patient she was pregnant and attempted to minimize the potential exposure to the fetus by having the patient increase fluid intake, to flush the free iodine from her system. The licensee also notified the patient's referring physician of the event. Ultrasound performed after identification of the pregnancy confirmed that the patient had been approximately 13-1/2 weeks pregnant with twins, at the time of the procedure.
The licensee does not expect the patient to experience any ill effects. The dose equivalent to each fetus was estimated to be about 0.38 sievert (Sv) (38 rem) and the dose equivalent to each fetal thyroid was estimated to be in excess of 2000 Sv (200,000 rem). The licensee expected that such a dose would result in the following likely effects to the fetuses: (1) thyroid ablation; (2) a 30 percent increase in the likelihood of microcephaly (small head size); (3) a 20 to 50 percent increase in the probability of childhood cancer; and (4) an increased probability for mental retardation. On the basis of this information, the patient elected to terminate the pregnancy.
Actions Taken To Prevent Recurrence
Licensee—The licensee modified its internal procedures for the administration of therapeutic radiopharmaceuticals, including diagnostic quantities of I131 in excess of 7.4 megabecquerel (MBq) [200 microcurie (mCi)]. All such procedures will include a statement that female patients between the ages of 10 and 55 years, without exception, prescribed to receive I131 dosages equal to or greater than 7.4 MBq (200 mCi) shall obtain a "beta serum pregnancy test" within 24 hours preceding administration.
NRC—The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the licensee's revised procedures and determined that they were adequate to address the cause of this medical event and to preclude similar events. The licensee complied with its "Quality Management Program" throughout this event and no NRC requirements were violated.
Event 3: Sodium Iodide Radiopharmaceutical Misadministration at Holy Redeemer Hospital and Medical Center in Meadowbrook, Pennsylvania
Date and Place—September 14, 1999; Holy Redeemer Hospital and Medical Center; Meadowbrook, Pennsylvania.
Nature and Probable Consequences—A patient's referring physician intended for the patient to receive a thyroid uptake and scan. The licensee routinely performed this procedure using iodine-123 (I123). However, because of an error, the patient was administered iodine-131(I131).
The authorized user intended to administer 11.1 megabecquerel (MBq) [0.300 millicurie (mCi)] of I123 to a patient for the evaluation of hyperthyroidism. However, no one prepared a written directive to indicate the type of thyroid procedure to administer. The patient was mistakenly listed on the licensee's schedule for a whole-body imaging as part of an evaluation for thyroid cancer therapy. The licensee routinely performs this type of procedure using I131. Therefore, the licensee's technologist administered a 196.1MBq (5.3mCi) dosage of I131 without obtaining a written directive. As a result of this error, the licensee's medical physicist determined that the patient's thyroid received an unintended dose of about 41.9 gray (4190 rad), based on a 65 percent uptake.
The U.S. Nuclear Regulatory Commission's (NRC's) consultant stated that the impact of the misadministration on the status of the patient's health should be negligible, with no expected long-term disability. The licensee believes that no harm was done to the patient because the patient's condition required additional thyroid treatment using I131. The patient was notified of the misadministration on September 16, 1999, and a written report was prepared. The patient's referring physician was also notified.
Actions Taken to Prevent Recurrence
Licensee—The licensee counseled the technologist on the importance of implementing the NRC regulations.
NRC—The NRC staff conducted a special safety inspection on September 17, 1999, and is evaluating enforcement options.
Event 4: Medical Event Involving the Administration of Iodine-131 to a Pregnant Patient at Via Christi Regional Medical Center in Wichita, Kansas
Date and Place—May 7, 1999; Via Christi Regional Medical Center; Wichita, Kansas.
Nature and Possible Consequences—A pregnant patient was administered a 436.6-megabecquerel (MBq) [11.8-millicurie (mCi)] dosage of Iodine-131 (I31) for a thyroid treatment.
Before the treatment, the technologist and the authorized user interviewed the patient about her pregnancy status and the patient certified that she was not pregnant and signed a consent form for the treatment. The patient then was administered the dosage of 436.6 MBq (11.8 mCi) of I131. Approximately 1 week after the I131 administration, during a routine gynecological exam, the patient learned that she was between 18 and 20 weeks pregnant.
A telephone report was made to the State of Kansas Radiation Control Program on May 12, 1999, and the State staff conducted an on-site investigation on May 13, 1999. It contacted the Department of Energy's Radiation Emergency Assistance Center/Training Site (REACTS) in Oak Ridge, Tennessee, for assistance. REACTS provided initial medical guidance and dosimetry calculations and agreed to act as consultant to the attending physician.
The dose equivalent to the fetus was estimated to be about 0.03 sievert (Sv) (3 rem) and the dose equivalent to the fetal thyroid was about 253 Sv (25,300 rem). The fetal thyroid dose was considered to be ablative. The authorized user notified the patient and her husband about the fetal exposure and the possible consequences.
Causes or Causes—The cause of the event was the licensee's assumption that the patient was not pregnant at the time of the I131 administration.
Actions Taken To Prevent Recurrence
Licensee—The licensee's radiation safety officer conducted an investigation and determined that the licensee's procedures and policies had been followed and that a reasonable effort had been made to determine the pregnancy status of the patient preceding the administration of I131. The licensee indicated a revision of its policy to require that all females of child-bearing age be tested for pregnancy preceding administration of therapeutic doses of radioactive material.
State Agency—The State staff conducted an investigation and agreed with the licensee's findings and believes that the licensee's proposal is adequate to prevent recurrence.
Event 5: Industrial Radiography Occupational Overexposure at Global X-ray and Testing Corporation in Aransas Pass, Texas
Date and Place—December 31, 1998; Global X-ray and Testing Corporation; Aransas Pass, Texas.
Nature and Probable Consequences—A radiography trainee failed to retract a 4.6-terabecquerel (123-curie) source of iridium-192 into the shielded position after taking a radiograph (exposure). As a result, the trainee received an estimated total effective dose equivalent of about 100 millisieverts (mSv) (10 rem) and an extremity annual shallow-dose equivalent of about 30,000 to 50,000 mSv (3000 to 5000 rem).
On December 31, 1998, a radiographer and a radiography trainee were working at a job site. At about 6:00 p.m., the radiography trainee thought that the radiography work was completed and removed a tool belt with a dosimeter and an alarming ratemeter and placed it in the truck. However, the radiographer asked the trainee for assistance to obtain additional radiographs. The trainee tried to take an additional radiograph, but the source would not crank and the trainee realized that the source was not retracted into the shielded position after the previous exposure. During this process, the trainee stood at the end of the guide tube for approximately 4 minutes at a distance of about 61 centimeters (2 feet) and touched the end of the guide tube where the source was located three or four times for about 2 or 3 seconds each time.
On January 10, 1999, signs of a radiation injury, such as redness, dry skin, and slight swelling accompanied by aching pain, appeared in the index finger of the trainee's right hand. On January 27, 1999, the finger developed a callous. On follow-up of the symptoms, it was indicated that the trainee received an extremity annual shallow-dose equivalent of about 30,000 to 50,000 mSv (3000 to 5000 rem).
Cause or Causes—The company's president told the office manager that the radiographer could act as a trainer because the paperwork requesting to name the individual radiographer as a trainer had been mailed to the State's Bureau of Radiation Control. Therefore, the radiographer was sent with the trainee to the job site. However, the radiation safety officer later told the office manager and the president of the company that Global X-ray and Testing Corporation had not yet received a license amendment naming the radiographer as a trainer.
The radiographer had been a trainer for several other radiography companies and was familiar with the requirements for a trainer working with a trainee. However, the radiographer was new with the company, was not familiar with this trainee, and was not aware that the trainee was not a radiographer. Therefore, the trainee was not appropriately supervised.
The trainee thought that the work for the day was completed and took the belt off and put it in the truck. The dosimeter and alarming rate meter were on the tool belt and were not used during the additional exposures. An operating survey meter was available, but the trainee did not use it during the radiographs.
Actions Taken To Prevent Recurrence
Licensee—The licensee met with all the radiography personnel to discuss the incident and make a presentation on radiation safety. Trainees were told to verify they were assigned to work with a trainer before leaving for a job site and radiographers were told to verify whether they were assigned to work with trainees. A memorandum stating these requirements was added to the licensee's safety training program. The office manager was given a written reprimand, which stated that another violation of any radiation regulation or safety policy would result in immediate termination of employment. The radiographer and the radiographer trainee had their employment terminated.
State Agency—The licensee was cited for violations of the radiation safety program and an escalated enforcement conference was conducted. As a result, inspection of the licensee's program and the radiographers' audit frequency was increased. A "Preliminary Report for Assessment of Administrative Penalties" was compiled and the licensee requested a settlement conference with the State agency.
Event 6: Industrial Radiography Overexposure to a Member of the Public at Professional Service Industries, Inc. in Seattle, Washington
Date and Place—December 16, 1998; Professional Service Industries, Inc.; Seattle, Washington.
Nature and Probable Consequences—The Washington State Department of Health was notified by Professional Service Industries, Inc. (PSI), that on December 16, 1998, a contractor's employee (member of the public) had accidentally handled a source guide tube containing a 2.22-terabecquerel (60-curie) iridium-192 radiography source at a temporary job site in Seattle, Washington.
A radiographer and a radiographer's assistant working for PSI were performing radiography at a large parking garage of an office building. The building entrances and the place where radiographs (exposures) were taken were properly posted. Two of the contractor's employees were allowed inside the parking garage, with the radiographer, to mark locations for future radiographs. The radiographer was talking with the contractor's employees while a radiograph was in process. One of the contractor's employees needed a ladder and approached the ladder in the garage that was being used to support the radiography source collimator. The radiography source collimator was positioned on the top of the ladder. The contract employee's actions dislodged the collimator from the source guide tube. The radiographer's assistant, who was monitoring the floor above the parking garage, came back to the garage and saw the contractor's employee trying to reassemble the collimator and the guide tube. The radiographer's assistant immediately shouted a warning and the radiographer, being alerted, ran to crank in the source to a safe position.
PSI's radiation safety officer (RSO) at the Seattle office and the corporate RSO were notified. PSI began an immediate investigation, including a re-enactment. Preliminary shallow-dose equivalent estimates for the extremities ranged from 6 to 17 sievert (Sv) (600 to 1700 rem). The Washington State Department of Health's Radiation Control Program was notified approximately 4 hours after the incident occurred and an investigation team was dispatched the next morning. The Washington Radiation Control Program estimated that the individual received a shallow-dose equivalent of: (1) 6.8 Sv (680 rem) to the right thumb; (2) 1 Sv (100 rem) to the right index finger; and (3) 1.7 Sv (170 rem) to the palm of the left hand. The total effective dose equivalent (TEDE) was estimated to be less than 0.05 Sv (5 rem). A cytogenetic study by the Department of Energy's Radiation Emergency Assistance Center/Training Site in Oak Ridge, Tennessee, determined that the TEDE was in the range of 0.01 to 0.15 Sv (1 to 15 rem).
No physical signs of radiation damage to the contract employee's hands were observed by the primary physician during the weeks after the incident. The exposed individual and his physician were kept informed of the findings of the investigation.
Cause or Causes—The cause of the incident was attributed primarily to the radiographer's failure to: (1) maintain direct surveillance of a radiography operation; and (2) warn individuals in the area that an exposure was underway.
Actions Taken To Prevent Recurrence
Licensee—PSI has complied with the corrective actions recommended by the State by: (1) completing a 2-day training for the Seattle PSI radiography personnel based on the incident; (2) accelerating the schedule of field audits of the PSI Seattle radiography personnel; and (3) performing a cytogenetic study for the contractor's employee.
State Agency—PSI was cited for violations that resulted in the overexposure of a member of the public and for failure to maintain direct surveillance of the radiography operation by allowing a member of the public to enter a high-radiation area.
Event 7: Gamma Stereotactic Radiosurgery (Gamma Knife) Misadministration at University of Maryland Medical Systems in Baltimore, Maryland
Date and Place—December 16, 1997; University of Maryland Medical Systems; Baltimore, Maryland. The State agency learned (through notification) of this misadministration on December 17, 1997, investigated the event, and completed the investigation on October 23, 1998.
Nature and Probable Consequences—A patient was prescribed a radiation therapy treatment using a gamma knife device for a brain metastasis involving three lesions. The patient was prescribed 1600 centigray (cGy) (1600 rad) to the first lesion. However, because of an error in the treatment plan, the first lesion received 2600 cGy (2600 rad).
The neurosurgeon prepared the treatment plan for the first lesion. While treating the first lesion, the neurosurgeon prepared the treatment plans for the second and third lesions. However, the treatment plan for the second lesion unintentionally included the settings for a treatment of a focal point of the first lesion. The neurosurgeon and the oncologist reviewed the treatment plans, but failed to identify any deviation from the prescribed dose. After the three lesions had been treated, the medical physicist who reviewed the dose calculations determined that an error occurred that resulted in an overdose to the first lesion. The licensee's oncologist determined that the administered overdose was within the range of acceptable prescribed dose for intra-cranial lesions. It was not anticipated that any complications would occur in addition to those normally seen with this type of therapy treatment.
The neurosurgeon notified the patient and the referring physician of the event on December 17, 1997. A letter confirming the discussion of the event was also sent to the patient on January 8, 1998. The patient died on January 20, 1998, of lung cancer.
Actions Taken To Prevent Recurrence
Licensee—The licensee immediately implemented measures to ensure that treatment will only be carried out after planning for all treatment sites is completed. The medical physicist will participate in the entire treatment planning process and will review the treatment plan before the plan is executed. The neurosurgeon and the oncologist will collaborate at critical points in the process, such as dose selection, approval of the written plan, and initiation of treatment.
State Agency—The licensee was cited for violations that included training deficiencies, failure of the radiation safety committee and the RSO to assume their duties and responsibilities, failure to apply for and receive license amendments before changing procedures, and failure to comply with notification requirements. Enforcement action is pending.
Event 8: Gamma Stereotactic Radiosurgery (Gamma Knife) Misadministration at Good Samaritan Hospital in Los Angeles, California
Date and Place—October 15, 1998; Good Samaritan Hospital; Los Angeles, California.
Nature and Probable Consequences—A patient was prescribed treatment of 9000 centigray (cGy) (9000 rad) to the left trigeminal nerve. However, the treatment was administered to the patient's right trigeminal nerve.
The licensee's medical physicist prepared a treatment plan for the wrong treatment site (right trigeminal nerve). The radiation oncologist, who was an authorized user on the license, signed the treatment plan without verifying the neurosurgeon's request, which listed the correct treatment site (left trigeminal nerve). Because the head restraint was positioned correctly on the patient, the medical physicist experienced difficulty positioning the patient in the gamma knife for the incorrect treatment site. In response to questions from the medical physicist, both the patient and the nurse informed him that the correct treatment site was the left trigeminal nerve. Inexplicably, this did not lead the medical physicist to recognize that he was about to treat the wrong trigeminal nerve. The error was discovered after the procedure was completed. As a result, the patient received a dose of 9000 cGy (9000 rad) to the wrong treatment site. During this procedure, the medical physicist was training another medical physicist on how to use the facility's gamma knife equipment. The patient's neurosurgeon was not present during this procedure because of a scheduling conflict, even though it was the licensee's standard practice for the neurosurgeon to be present.
Treatment of the intended left trigeminal nerve was postponed pending evaluation of the medical outcome of the treatment of the wrong trigeminal nerve. The patient's physician stated that the patient might experience increasing numbness on the affected area of the face within 1 to 18 months. If the numbness occurs, it may affect the plan for treating the prescribed left site.
Cause or Causes—The misadministration occurred because: (1) the medical physicist prepared a treatment plan for the wrong treatment site; (2) the radiation oncologist signed the treatment plan without properly verifying it; and (3) the neurosurgeon was not present during the procedure, which differed from standard licensee practice. The radiation oncologist had not conferred with the patient before the treatment, which may have contributed to the incorrect site treatment. Although it is possible that his training of the other medical physicist distracted the medical physicist, this could not be determined as a contributing cause.
Action Taken To Prevent Recurrence
Licensee—The licensee revised the gamma knife treatment procedure to require that: (1) the treatment plan be verified before each procedure by the neurosurgeon, the radiation oncologist, and the medical physicist; (2) two of the three individuals (the neurosurgeon, the radiation oncologist, and the medical physicist) verify that the treatment program coordinates are correctly set; (3) either the neurosurgeon or the radiation oncologist verify the prescribed treatment site after the patient is positioned; and (4) the neurosurgeon and either the radiation physicist or the radiation oncologist be physically present during the treatment. Also, the radiation oncologist shall examine the patient before the treatment and verify the treatment site.
State Agency—The State cited the licensee for failure to report the therapeutic misadministration within 24 hours as required. The licensee was also cited for failure of the authorized user to verify the dosimetry plan and treatment programming.
Event 8: Therapeutic Radiopharmaceutical Misadministration of Iodine-131 to the Wrong Individual at Hermann Hospital in Houston, Texas
Date and Place—August 4, 1999; Hermann Hospital; Houston, Texas.
Nature and Possible Consequences—A patient was scheduled to receive a 10.10-megabecquerel (27.3-millicurie) dosage of iodine-131 (I131) for a thyroid treatment. However, because of an identification error, the wrong individual was administered the I131.
Two middle-aged female Asian patients were at the licensee's nuclear medicine department for different procedures. The patient who was scheduled to receive the I131 dosage left the waiting room. The licensee's technologist approached the other patient to verify her name and date of birth by stating the name and date of birth of the patient who was to receive the I131 treatment. The patient responded with "yes," although she did not understand the questions. She also indicated she understood the instructions previously given to her about the I131 treatment. Therefore, she was administered the dosage of I131. Later it was found that the I131 was administered to the wrong individual. The licensee ordered another dosage of I131, which was administered to the correct patient as prescribed.
The licensee estimated that: (1) the dose to the patient's thyroid as a result of the misadministration was about 220 gray (22,000 rad); (2) the patient has about an 85 percent chance of losing thyroid function; and (3) replacement thyroid hormone will be required indefinitely. The patient's attending physician was contacted and remedial action was taken.
Actions Taken To Prevent Recurrence
Licensee—The licensee has changed procedures for all outpatient therapy treatments that involve radioactive materials. The format of questions for patient identification will be revised to read "What is your name?" and "What is your date of birth?" instead of "Is your name ...?" or "Is your date of birth ...?" Outpatients will also be asked to show a picture form of identification. In the case of pediatric patients, the child's parent or guardian must confirm the patient's identification.
State Agency—The licensee was cited for administering a therapeutic dosage of I131 to the wrong individual, who had a normally functioning thyroid, and for the authorizing physician user not being physically present when therapy procedures were being performed. Enforcement action is pending. Event 9: Therapeutic Radiopharmaceutical Misadministration of Samarium-153 at Merle West Medical Center in Klamath Falls, Oregon
Date and Place—March 10, 1999; Merle West Medical Center; Klamath Falls, Oregon.
Nature and Probable Consequences—A patient with metastatic prostate cancer was prescribed a dosage of 2294 megabecquerel (MBq) [62 millicurie (mCi)] of samarium-153 (Sm153) to palliate bone pain. However, because of an error, the patient was administered a dosage of 3589 MBq (97 mCi) of Sm153. The recommended dosage for the Sm153 procedure is 37 MBq (1 mCi) per kilogram (kg) [2.2 pounds (lbs)] of body weight.
The misadministration resulted in an additional dose of 200 centigray (cGy) (200 rad) to the bone marrow. The patient's other organs received additional doses that were below 1000 cGy (1000 rad). The hospital checked with the manufacturer, DuPont Merck Pharmaceutical Company, concerning possible side effects of the misadministration. The pharmaceutical company indicated that other studies have been done using 74 to 92.5 MBq per kg (2.0 to 2.5 mCi per 2.2 lb) of Sm153, with no significant side effects.
Both the attending physician and the patient's family were notified of the misadministration.
Cause or Causes—This event was caused by a human error. The licensee indicated that the dosage was calculated using the patient's weight in pounds instead of kilograms.
Actions Taken To Prevent Recurrence
Licensee—The incident was discussed with the Radiation Safety Committee (RSC). The licensee revised its Quality Management Program (QMP) for the use of Sm153 and strontium-89 therapy to require the prescribing physician to calculate and personally order the dosage. The RSC approved the changes to the QMP. The technologist involved in the procedure was counseled concerning therapy procedures, dosage administrations, and the importance of rechecking calculations.
State Agency—The State cited the licensee for failure to report the misadministration within the required time.
(Contact: Gary Purdy, NMSS, 3014157897, e-mail: firstname.lastname@example.org )
Comments, and suggestions you may have for information that is not currently being included, that might be helpful to licensees, should be sent to:
NMSS Licensee Newsletter Editor
Office of Nuclear Material Safety
Two White Flint North, Mail Stop 8-A-23
U.S. Nuclear Regulatory Commission
Washington, D.C. 20555-0001
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Page Last Reviewed/Updated Wednesday, March 24, 2021