The U.S. Nuclear Regulatory Commission (NRC) plans to streamline both inspection and enforcement, for all materials licensees. NRC will begin this new approach with two 1-year pilot programs. One will be for certain medical use licenses, specifically for nuclear medicine programs (use under 10 CFR 35.100, 35.200, and 35.300), beginning in calendar year 1999. These licenses represent approximately 30 percent of current NRC material licenses. The other pilot program, also planned to begin in 1999, will be for fuel cycle facility licensees.
NRC is developing inspection and enforcement guidance for each of these two pilot programs. The guidance will focus attention on elements of the licensee's program performance having potential for significant health and safety outcomes. The central element of this new approach will be the use of performance indicators for program review. These indicators will consist of a limited number of key factors, each related to an important health and safety outcome. Collectively, they will be used to provide an overall assessment of the adequacy and acceptability of the licensee's radiation protection and materials control program performance. Lessons learned in this area will be applied to inspection and enforcement guidance for other areas.
This initiative is expected to improve the inspection and enforcement process for both the licensees and NRC, by reducing the impact of inspections and the regulatory burden on licensees, and more effectively using NRC resources. To make the public aware of these initiatives and to provide an opportunity for public input and comment, a public meeting was held on January 8, 1999, in Rockville, MD, focusing on the medical licensee inspection pilot program.
A electronic copy of the draft inspection guidance for the medical licensee inspection pilot program can be accessed on NRC's Homepage (http://www.nrc.gov) under "What's New."
(Contact: Dr. Ronald Zelac, NMSS, 301-415-6316; e-mail: email@example.com)
In June 1997, Private Fuel Storage, Limited Liability Company (PFS) submitted an application to the U.S. Nuclear Regulatory Commission (NRC), pursuant to 10 CFR Part 72, to construct and operate an away-from-reactor independent spent fuel storage installation (ISFSI). This was only the second application submitted to NRC for an away-from-reactor ISFSI and the first for storage of spent fuel from more than one utility.(1) PFS is a consortium of nuclear utilities that has arranged to lease land for the proposed ISFSI from the Skull Valley Band of Goshute Indians (the Skull Valley Band). The PFS application seeks approval for the storage of a maximum of 40,000 metric tons of uranium (40,000 short tons of uranium) spent fuel at the site.
The Skull Valley Band is a Federally-Recognized Indian Tribe whose reservation is located approximately 60 miles west of Salt Lake City, Utah. The reservation is bordered on all sides by Tooele County, Utah, a geographically large jurisdiction with a relatively small population. The Skull Valley Band has been interested in hosting a spent fuel storage facility since the days of the Department of Energy's Monitored Retrievable Storage (MRS) and Nuclear Waste Negotiator programs. It studied the issue before deciding to seek to host, first the MRS, and then the PFS facility.
Because this facility, if licensed, will not be located at a nuclear power plant, PFS will need to transport and store the spent fuel in dual-purpose cask systems, approved by NRC pursuant to the storage cask requirements in Part 72 and the transportation cask requirements in 10 CFR Part 71. PFS has proposed the use of Holtec International's HISTAR/HISTORM dual-purpose cask system and BNFL/SNC's TranStor dual-purpose cask system. Since both of these cask systems are currently undergoing certification review by the NRC staff, the PFS application cannot be finally approved until at least one of them has been certified and PFS has taken the necessary actions to demonstrate that the cask systems, as approved for general use by the staff, are also acceptable for use specifically at the PFS site.
After the PFS application was received, several parties sought standing to intervene in the proceedings. An Atomic Safety Licensing Board (ASLB) was empaneled and several groups were granted standing. These included: the State of Utah; Ohngo Gaudadeh Devia (members of the Skull Valley Band who oppose the facility); the Confederated Tribes of the Goshute Reservation (a separate Federally-Recognized Indian Tribe with a reservation located on the Utah/Nevada border, that has some family and cultural ties to the Skull Valley Band); the Skull Valley Band itself; and Castle Rock Land and Livestock, L.C./Skull Valley Company, LTD (Castle Rock). Castle Rock represents ranching and farming interests on the Reservation's borders(2) Approximately 25 contentions were eventually accepted by the ASLB. These contentions must be adjudicated before a license can be granted to PFS.
The SpentFuel Project Office staff and its contractors at the Center for Nuclear Waste Regulatory Analyses are carrying out the safety review of the PFS application. The staff recently sent its second request for additional information (RAI) on safety issues to PFS. We anticipate completing the site-specific safety review by October 1999, with the full safety review to be completed 1 year later following completion of cask certification proceedings. The staff, with the assistance of Oak Ridge National Laboratories, is also preparing an Environmental Impact Statement (EIS). An EIS scoping meeting was held in Salt Lake City, UT, in May of 1998. A first environmental RAI was recently sent to PFS. A draft EIS is scheduled for October 1999, with a final EIS to be published 1 year later, after which hearings on environmental issues will be held. Current schedules anticipate a completion of all licensing and EIS development activities by September of 2000. However, adjudication is expected to continue past September 2000, and the ASLB's initial decision is expected to be issued in 2001.
(Contact: Mark Delligatti, NMSS, 301-415-8518; e-mail: firstname.lastname@example.org)
In June 1998, the U.S. Nuclear Regulatory Commission (NRC) was informed of a positive leak test result of a Nuclear Associates Model 69 brachytherapy source. This source had been removed from service and placed in a shielded storage container since 1981. NRC had been notified, in June 1992, of another leaking Nuclear Associates brachytherapy source, also in storage.
The State of California had recognized a problem with these sources--namely, they had been distributed without the knowledge or approval of the State around 1979. NRC had previously issued an Agreement State Letter on May 14, 1981, advising on the same subject. California had advised users of these sources to visually examine and leak test before and after each use.
NRC believes that these sources are still being licensed for storage and/or use. Although these events appear uncommon, NRC is concerned that these sources may have the potential to leak. Licensees that possess these sources should recognize such a potential, review their leak test protocol, and take action appropriately.
(Contact: Eric Compton, NMSS, 301-415-5799, e-mail: email@example.com)
In 1959, Section 274 of the Atomic Energy Act was enacted to define 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). 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 an agreement, thus becoming the first Agreement State.
Today, 30 States have entered into Agreements with NRC and five others are currently being negotiated. In December 1964, the former Atomic Energy Commission hosted the first Annual Joint Meeting with a group of Agreement States. Sometime later, State program directors came together to form the Organization of Agreement States (OAS).
The OAS Executive Committee is composed of a chairman, past-chairman, chairman-elect, and secretary. The chairman is designated as the principal point of contact for the OAS.
As of January 1, 1999, Mr. Stan Marshall, Nevada's Radiation Control Program Director, began his term as Chairman of the Organization of Agreement States. Mr. Marshall is a 1974 graduate from Purdue University in environmental health/radiation physics. He has managed the Nevada program since 1986, after experience in the Nevada and Indiana radiation control programs since 1977, and in other public health protection programs since departing from post-graduate work in radiation physics/ bionucleonics at Purdue.
The following is a complete listing of OAS Executive Committee members:
|Stanley R. Marshall, Supervisor--Chairman
Radiological Health Section
Bureau of Health Protection Services
Nevada State Health Division
1179 Fairview Drive, Suite 102
Carson City, NV 89701-5405
Phone: 775-687-5394, x276
|Edgar D. Bailey, CHP, Chief--Chairman-Elect|
Radiologic Health Branch
Food, Drugs & Radiation Safety Division
California State Department of Health Services
P. O. Box 942732
Sacramento, CA 94234-7320
|Roland Fletcher, Manager--Past-Chairman
Radiological Health Program
Air and Radiation Management Administration
Maryland Department of Environment
2500 Broening Highway
Baltimore, MD 21224
|Richard A. Ratliff, P.E., LMP, Chief--Secretary|
Bureau of Radiation Control
Texas Department of Health
1100 West 49th Street
Austin, TX 78756-3189
(General Contact: Rosetta Virgilio, OSP, 301-415-2307, e-mail: firstname.lastname@example.org)
A number of management positions in the Office of Nuclear Material Safety and Safeguards (NMSS) have changed in the last several months. Martin J. Virgilio has moved from the Office of the Chairman, where he was Executive Assistant and Director of the Office, to become Deputy Director of NMSS. Mr. Virgilio replaced Malcolm R. Knapp, who has moved to the position of Deputy Executive Director for Regulatory Effectiveness. Michael F. Weber has moved from a position as Deputy Director of the Division of Waste Management (DWM) to succeed Mr. Virgilio in the Chairman's Office. Joseph J. Holonich has replaced Mr. Weber as Deputy Director of DWM.
William F. Kane, formerly Director of the Spent Fuel Project Office (SFPO) in NMSS, has been named Associate Director for Inspection and Programs in the Office of Nuclear Reactor Regulation. E. William Brach has succeeded Mr. Kane as Director of SFPO.
(Contact: Paul Goldberg, 301-415-7842, e-mail: email@example.com)
Detailed information about these enforcement actions can be accessed via the U.S. Nuclear Regulatory Commission (NRC) homepage [http://www.nrc.gov/]. Click on "About NRC,"
click on "Enforcement Program," click on "Enforcement Actions Issued," and click on either "Escalated Enforcement Actions Issued to Materials Licensees Since March, 1996," or "Enforcement Actions Issued to Individuals." Cases are listed alphabetically. To access the complete enforcement action, click on the highlighted text following the name of the case.
United States Enrichment Corporation, Bethesda, Maryland, EAs 98-249 to 98-251. A $55,000 civil penalty was assessed based on a programmatic deficiency in the maintenance and surveillance program for air-operated, safety-related valves at the Portsmouth plant. Routine functional tests were not performed and numerous valves were not capable of meeting the test acceptance criteria.
Brucker Engineering, Ltd., St. Louis, Missouri, EA 98-326. A Severity Level III violation was issued based on failure to secure or control licensed material in an unrestricted area.
Engineering Surveys and Services, Inc., Columbia, Missouri, EA 98-386. A Severity Level III violation was issued based on failure to secure or limit access to a moisture density gauge, which was damaged by heavy construction equipment.
Geotechnical Consultants, Inc., Westerville, Ohio, EA 98-385. A Severity Level III violation was issued based on failure to secure or control licensed material. Specifically, a gauge was left in an unlocked vehicle with the key in the ignition.
KTI Construction Services, Inc., Merriam, Kansas, EA 98-377. A Notice of Violation was issued for four violations considered in the aggregate to represent a Severity Level III problem. The violations involved failure to maintain control of licensed material, use by an unauthorized person, failure to wear a film badge, and failure to follow emergency procedures.
The Terracon Companies, Inc., Lenexa, Kansas, EA 98-124. A $2750 civil penalty was assessed for failure to adequately secure a portable moisture/ density gauge, resulting in its theft from a vehicle.
Jose N. DeLeon, M.D., Isla Verde, Puerto Rico, EA 97-627. A $5000 civil penalty was assessed based on failure to establish and maintain a written quality management program for strontium-90 eye brachytherapy, which resulted in nine misadministrations.
Alaron Corporation, Wampum, Pennsylvania, EA 98-144. A $5500 civil penalty was assessed and a Demand for Information was issued because the licensee willfully violated the license by failing to dispose of waste that had been in storage for more than 2 years.
Baxter Healthcare Corporation of Puerto Rico, Aibonito, Puerto Rico, EA 97-518. A $10,500 civil penalty was assessed for willfully disabling a roof plug safety interlock switch and bypassing its associated circuitry, and willfully performing multiple unauthorized repairs of the irradiator control console and safety systems.
Breitling USA, Inc., Stamford, Connecticut, EA 98-163. Civil penalties totaling $26,400 were assessed and a Demand for Information was issued because the company did not have the required NRC licenses for its possession, use, and distribution of watches containing tritium.
Conam Inspection, Inc., Glendale Heights, Illinois, EA-404. A Severity Level III violation was issued based on failure to secure a radiography device from unauthorized removal.
Met-Chem Testing Laboratories of Utah, Inc., Salt Lake City, Utah, EA 98-362. A Severity Level III violation was issued for failure to maintain control over licensed material, based on an incident in which a radiography device was left behind at a temporary job site.
Cardinal Surveys Company, Odessa, Texas, EA 98-347. A Severity Level III violation was issued based on failure to file an NRC Form 241, as required pursuant to 10 CFR 150.20, for activities conducted in an NRC-regulated State by an Agreement State licensee.
(Contact: Joseph DelMedico, OE, 301-415-2739, e-mail: firstname.lastname@example.org )
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. The Internet address for the NRC library of generic communications is-- www.nrc.gov/NRC/GENACT/GC/index.html. Please note that this address is case-sensitive and must be entered exactly as shown.
AL 98-08, "AVAILABILITY OF REVISED NRC FORM 3, NOTICE TO EMPLOYEES, AND CLOSURE OF NRC WALNUT CREEK FIELD OFFICE," was issued on October 9, 1998, to all NRC licensees. It notifies them of changes, to NRC Form 3, concerning discrimination complaints and the closure of the NRC field office in Walnut Creek, CA.
Contact: Carl Mohrwinkel, NRR, 301-415-1293, e-mail: email@example.com
IN 98-35, "THREAT ASSESSMENTS AND CONSIDERATION OF HEIGHTENED PHYSICAL PROTECTION MEASURES," was issued on September 4, 1998, to licensees required to have safeguards programs under 10 CFR Part 73. The notice contains safeguards information and distribution is restricted.
Contacts: Eugene McPeek, NRR, 301-415-3210, e-mail: firstname.lastname@example.org, John Davidson, NMSS, 301-415-8130, e-mail: email@example.com
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: firstname.lastname@example.org)
NOTE: U.S. Nuclear Regulatory Commission (NRC) contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
"Criticality Accident Requirements," 63 FR 63127, November 12, 1998. Contact: Michael T. Jamgochian (301) 415-3224; e-mail: email@example.com
"Streamlined Hearing Process for NRC Approval of License Transfers," 63 FR 66721, December 3, 1998. Contacts: James A. Fitzgerald, 301-415-1607,
e-mail: firstname.lastname@example.org , Leo Slaggie, 301-415-1605 (TDD), e-mail: email@example.com
"Fee for Services To Support FEMA's Offsite Radiological Emergency Preparedness Program," (Interim final rule with request for comments), 63 FR 69001, December 15, 1998. Contact: Vanessa E. Quinn, Preparedness, Training, and Exercises Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, 202-646-3664; fax: 202-646-3508; e-mail: firstname.lastname@example.org
"Fee for Services to Support FEMA's Offsite Radiological Emergency Preparedness Program, " (hourly rate), 63 FR 69075, December 15, 1998. Contact: D. Anne Martin, Acting Division Director, Exercises Division, Preparedness, Training and Exercises Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, 202-646-2738; e-mail: email@example.com
"Transfer of Rulemaking Functions," 63 FR 69543, December 17, 1998. Contact: Alzonia Shepard, 301-415-6864; e-mail: firstname.lastname@example.org
"Procedures Applicable to Proceedings for the Issuance of Licenses for the Receipt of High- Level Radioactive Waste at a Geologic Repository," 53 FR 71729, December 30, 1998. Contact: Kathryn L. Winsberg, 301-415-1641; e-mail: email@example.com
"Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material To Provide Requested Information," 63 FR 66492, December 2, 1998. Contacts: Catherine R. Mattsen, 301-415-6264; e-mail: firstname.lastname@example.org , Jayne McCausland, 301-415-6219; e-mail: email@example.com
"Comprehensive Quality Assurance in Medical Use and a Standard of Care," withdrawal of Advance Notice of Proposed Rulemaking, 63 FR 66496, December 2, 1998. Contact: Jayne McCausland, 301-415-6219; e-mail: firstname.lastname@example.org
"Elimination of Inconsistencies Between NRC Regulations and EPA High-Level Waste Standards," withdrawal of Advance Notice of Proposed Rulemaking, 63 FR 66498. Contact: Tim McCartin,301-415-6681; e-mail: email@example.com
Withdrawal of advance notice of proposed rulemaking, "Distribution of Source and Byproduct Material: Licensing and Reporting Requirements," 63 FR 68700, December 14, 1998. Contact: Catherine R. Mattsen, 301-415-6264; e-mail firstname.lastname@example.org
Withdrawal of proposed rule, "Requirements Concerning the Accessible Air Gap for Generally Licensed Devices," 64 FR 3052, January 20, 1999. Contact: Jayne M. McCausland, 301-415-6219; e-mail: email@example.com
"Memorandum of Understanding Between the Nuclear Regulatory Commission and the Department of Energy Governing Nuclear Regulatory Commission Funded Work Performed at the Department of Energy Laboratories," 64 FR 3986, January 26, 1999. Contact: Mary Lynn Scott, 301-415-6179; e-mail: firstname.lastname@example.org
"Supplemental Information on the Implementation of the Final Rule on Radiological Criteria for License Termination," 63 FR 64132, November 18, 1998. Contacts: David N. Fauver, 301-415-6625; e-mail: email@example.com, Rateb (Boby) Abu Eid, 301-415-5811; e-mail: firstname.lastname@example.org
Notice of Availability of NUREG-1556, Volume 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses,'' 63 FR 67495, December 7, 1998. Contact: Sally L. Merchant, 301-415-7874; e-mail: email@example.com
Notice of Availability of draft NUREG-1556, Volume 10, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Materials Licenses,'' 63 FR 67495, December 7, 1998. Contact: Sally L. Merchant, 301-415-7874; e-mail: firstname.lastname@example.org
"State of Maine: Discontinuance of Certain Commission Regulatory Authority and Responsibility Within The State: Republication," 63 FR 67945, December 9, 1998. Contact: Thomas J. O'Brien, 301-415-2308; e-mail: email@example.com
Notice of Availability of NUREG-1556, Volume 5, " Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses, " 63 FR 69122, December 15, 1998. Contact: Sally L. Merchant, 301-415-7874; firstname.lastname@example.org
Notice of Issuance, Availability; NUREG-1307, Revision 8, "Report on Waste Burial Charges," 63 FR 71172, December 23, 1998. Contact: John W. Craig, 301-415-6207; e-mail: email@example.com
"Policy and Procedure for Enforcement Actions; Fuel Cycle Facilities Civil Penalties and Notices of Enforcement Discretion (NUREG-1600)," 63 FR 71314, December 24, 1998. Contact: James Lieberman, 301-415-2741; e-mail: firstname.lastname@example.org
"Domestic Licensing of Special Nuclear Material; Request For Public Comments on Rulemaking Activities," 63 FR 71232, December 24, 1998. Contacts: Theodore S. Sherr, 301-415-7218; e-mail: email@example.com, Andrew Persinko, 301-415-6522; e-mail: firstname.lastname@example.org, Barry T. Mendelsohn, 301-415-7270; e-mail: email@example.com
"Notice of Availability of Staff Draft Proposed Rule Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material," 63 FR 72216, December 31, 1998. Contact: Catherine R. Mattsen, 301-415-6264; e-mail: firstname.lastname@example.org
"NRC Enforcement Policy; Discretion Involving Natural Events," (NUREG-1600, Rev. 1), 64 FR 915, January 6, 1999. Contact: James Lieberman, 301-415-2741, e-mail: email@example.com
"List of Approved Spent Fuel Storage Casks: Addition," 64 FR 1542, January 11, 1999. Contacts: Stan Turel, 301-415-6234; e-mail: firstname.lastname@example.org , Philip Brochman, 301-415-8592; e-mail: email@example.com
Nuclear Information and Resource Service; Receipt of Petition for Rulemaking to Shut Down Nuclear Facilities Not Y2K-Compliant, 64 FR 3790, January 25, 1999. Contact: David L. Meyer, 301-415-7162 or toll-free: 1-800-368-5642; e-mail: firstname.lastname@example.org
Notice of availability; Opportunity for comment. "NUREG-1620, Draft Standard Review Plan: Review of a Reclamation Plan for Mill Tailings Sites Under Title II of the Uranium Mill Tailings Radiation Control Act," 64 FR 5321, February 3, 1999. Contact: Banad Jagannath: 301-415-6653; e-mail: email@example.com
Withdrawal of Regulatory Guide 10.10, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material'' (issued March 1987), and Regulatory Guide 10.11, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material" [superseded by NUREG-1556, Vol.3], 64 FR 6721, February 10, 1999.
Issuance and Availability of "Spent Fuel Heat Generation in an Independent Spent Fuel Storage Installation,Rev. 1,'' 64FR 6922, February 11, 1999.
Notice of Availability for NUREG-1671, "Standard Review Plan for the Recertification of the Gaseous Diffusion Plants; Notice of Availability," 64 FR 8412, February 19, 1999. Contact: Charles Cox, 301-415-6755; e-mail: firstname.lastname@example.org
(General Contact: Paul Goldberg, NMSS, 301-415-7842; e-mail: email@example.com)
Event 1: Seismic Risk from Liquid Uranium Hexafluoride at the Withdrawal Facilities at the Paducah Gaseous Diffusion Plant
Date and Place--February 18, 1998; Paducah Gaseous Diffusion Plant (Paducah), a uranium enrichment plant, operated by Lockheed Martin Utility Services for the United States Enrichment Corporation (USEC) and located about 16 kilometers (10 miles) west of Paducah, Kentucky.
Nature and Probable Consequences--On October 31, 1997, USEC submitted a certificate amendment request that provided an updated Safety Analysis Report, including a new accident analysis, for Paducah. The seismic accident analysis identified that equipment (piping, condensers, and accumulators) in the withdrawal facilities containing liquid uranium hexafluoride (UF6) could fail at a 70-year return earthquake [0.05 g peak ground acceleration (pga)] rather than the 250-year return design basis earthquake (0.15 g pga). However, the accident analysis consequences were identified as minimal because of the assumptions made in the accident analysis. A U.S. Nuclear Regulatory Commission (NRC) request for additional information (RAI) dated February 5, 1998, identified questions about the conservative nature of assumptions for the seismic accident analysis. In response to the RAI, USEC confirmed that the seismic accident analysis assumption of no liquid UF6 in the withdrawal facilities' accumulators underestimated the potential source term for the seismic accident analysis.
The accumulators are normally empty and serve only as a reservoir for liquid UF6 when cylinders are changed after being filled or during periods of equipment problems or surveillances. However, with no operational restrictions on the amount of liquid UF6 in the accumulators, a seismic event could occur with the accumulators full. Consequences from a 0.05 g pga earthquake with full accumulators in the withdrawal facilities could include onsite fatalities and significant offsite injuries from exposure to the released UF6 and reaction products.
Cause or Causes--The cause of this event was an inadequate seismic design for the facility and an inadequate accident analysis that did not consider the full range of allowable operations of the withdrawal facilities.
Actions Taken to Prevent Recurrence:
Licensee/Certificate Holder--Immediate corrective actions included restricting operations in the withdrawal facilities to limit the amount of liquid UF6 available for release. Long-term corrective actions are to install seismic modifications that will allow the withdrawal facilities' equipment to withstand a design basis earthquake. USEC has committed to completing the seismic modifications by September 30, 1998.
NRC--An immediately effective confirmatory order incorporating the immediate and long-term corrective actions was issued and potential escalated enforcement action is being considered. This event is closed for the purpose of this report.
Other NRC Licensees
(Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
Event 2: Iodine-131 Medical Misadministration at Virginia Beach General Hospital, in Virginia Beach, Virginia
Date and Place--November 21, 1997; Virginia Beach General Hospital; Virginia Beach, Virginia.
Nature and Probable Consequences--A patient was administered a dosage of 199.8 megabecquerel (MBq) [5.4 millicurie (mCi)] of iodine-131 (I-131) for a thyroid procedure, instead of a 11.1 MBq (0.300-mCi) dosage of iodine-123 (I-123). As a result, the patient's thyroid received a dose of 4000 centigray (cGy) (4000 rad), instead of the intended dose of 2.0 cGy (2.0 rad).
On November 20, 1997, the referring physician prescribed a thyroid function procedure that, at Virginia Beach General Hospital, required the administration of about 11.1 MBq (0.300 mCi) of I-123. Because of a miscommunication between the referring physician and her staff (a staff nurse), the patient was scheduled for a whole-body thyroid scan that required the administration of approximately 185 MBq (5 mCi) of I-131. On November 21, 1997, the technologist involved in the procedure attempted to contact the referring physician to ask questions about the requested procedure. However, the referring physician was not available, and the staff nurse who had originally taken the request from the referring physician and scheduled the procedure confirmed that the physician wanted an iodine-131 scan. The technologist, without a written directive, decided to proceed with the procedure and administered the dosage of 199.8 MBq (5.4 mCi) of I-131 to the patient. The misadministration was identified on November 24, 1997, when the patient returned for a 72-hour whole-body scan.
The licensee stated that no adverse health effects are expected from the misadministration. The Nuclear Regulatory Commission's (NRC's) medical consultant determined that the impact of the misadministration on the patient's health should be negligible, with no expected long-term disability.
Cause or Causes--The cause of the event was the licensee's failure to prepare a written directive before the administration of the I-131 dosage and inadequate follow-up by the technologist involved in the I-131 procedure.
Actions Taken to Prevent Recurrence
Licensee--New procedures were initiated that required all I-131 procedures to be scheduled through the nuclear medicine department, and additional quality management measures were implemented. In addition, the licensee initiated changes to the computerized scheduling system and provided retraining of the staff.
NRC--An inspection was conducted to review the circumstances of the misadministration. A Notice of Violation was issued for the licensee's failure to prepare a written directive before the administration of iodine-131.
This event is closed for the purpose of this report.
Event 3: Exposure to a Minor from a Radiopharmaceutical Therapy Event at Western Pennsylvania Hospital in Pittsburgh, Pennsylvania
Date and Place--July 28, 1998; Western Pennsylvania Hospital; Pittsburgh, Pennsylvania
Nature and Probable Consequences--A female patient was prescribed a whole-body iodine-131 (I-131) thyroid scan, after a thyroidectomy, because of a thyroid cancer. The technologist asked the patient whether she was breast-feeding, but she did not provide an answer and was administered 111 megabecquerel (MBq) (3 millicurie) of I-131. Two days later while performing the scan, the patient indicated that she had breast-fed her 4-year old son during the past few evenings. The licensee performed a bioassay on the child on August 3, 1998, and determined that the total effective dose equivalent for the child, based on the International Commission on Radiological Protection calculations, was 89.5 millisievert (8.95 rem), and the dose to the thyroid was about 184 centigray (cGy) (184 rad).
The U.S. Nuclear Regulatory Commission (NRC) medical consultant evaluated the event and estimated that the dose to the child's thyroid, using the Medical Internal Radiation Dose calculations, to be about 128 to 152 cGy (128 to 152 rad) and provided a discussion of potential clinical consequences.
The hospital was notified of the consultant's findings and was provided a copy of the consultant's report. The child has been examined by a pediatric endocrinologist and the hospital continues to monitor the patient and her child.
Cause or Causes--The patient's failure to answer the technologist's question regarding breast feeding and the hospital's failure to receive an answer to the question before dose administration.
Action Taken to Prevent Recurrence:
Licensee--Developed a new form for women of ages between 10 to 50 years old for: (1) asking them if they are nursing; (2) informing them of the harm to a child if they are breast-feeding after I-131 administration; and (3) obtaining a signed statement before patient dose administration.
NRC--NRC issued a letter requiring the licensee to provide a plan describing prevention of similar events. The licensee provided a response dated October 8 and 12, 1998, listing adequate actions to prevent recurrence of similar events.
This event is closed for the purpose of this report.
Medical Brachytherapy Misadministration at Tuomey Regional Medical Center in Sumter, South Carolina
The following information about this event is also being reported concurrently in the Federal Register. Appendix A (see Criterion I.A.1, "For All Licensees") of this report states that any unintended radiation exposure to an adult (any individual 18 years of age or older) resulting in an annual total effective dose equivalent of 250 millisievert (mSv) (25 rem) or more; or an annual sum of the deep dose equivalent and committed dose equivalent to any individual organ or tissue other than the lens of the eye, bone marrow, and the gonads, of 2500 mSv (250 rem) or more, will be considered for reporting as an Abnormal Occurrence.
Date and Place--September 23, 1997;
Tuomey Regional Medical Center; Sumter, South Carolina.
Nature and Probable Consequences--On September 23, 1997, a patient was prepared for a palladium-103 (Pd-103) permanent prostate seed implant via transrectal ultrasound guidance. The patient was identified by verbal means (asking the patient's name) and by identifying the name of the patient on his wristband. In addition, the patient had signed a consent in the chart stating he was at the hospital for seed implants for treatment of prostate cancer. The patient received 67 seeds of Pd-103 at 37 megabecquerel (1 millicurie) per seed; thus, he received a total implant activity of 2479 megabecquerel (67 millicurie). The patient was offered post-implant dosimetry planning, which he refused. Based on pre-implant dosimetry, the periphery of the prostate was to receive a maximum dose of 9000 centigray (9000 rad). The posterior wall of the bladder and anterior wall of the rectum would receive approximately 4000 centigray (4000 rad) and the whole-body dose would be less than 1 centigray (1 rad). The procedure was performed without complication.
On September 25, 1997, Tuomey Regional Medical Center was notified by the patient's urologist that he had two patients with identical names and the wrong patient had received the implant. On September 29, 1997, the authorized user met with the patient on whom the procedure was performed. The potential early and late side effects, and all necessary precautions, were discussed.
The licensee stated the early consequences from this type of implant usually are dysuria and possible hematuria, which if they occur, resolve in several days. Late consequences could be an approximately 25 percent chance of impotence. Damage to the bladder and rectum occurs in less than 1 percent of patients.
Cause or Causes--The referring physician (urologist) had two patients with identical names. The wrong patient arrived at Tuomey Regional Medical Center with orders from the referring physician for the Pd-103 seed implant. This patient should not have had these orders. The correct patient had been to Tuomey Regional Medical Center for a pre-operative interview. When the wrong patient appeared for treatment at Tuomey Regional Medical Center, the registration process did not identify that this individual was different from the individual who had been present for the pre-operative interview.
Actions Taken To Prevent Recurrence
Licensee--The licensee performed a comprehensive review of the patient identification process, on occurrence of the incident. As a result, the patient identification system was revised on a hospital-wide basis, to prevent recurrence of this type of event.
State Agency--The State Agency conducted an investigation of the event and a Notice of Violation and Enforcement Conference was held on February 10, 1998. A Notice of Noncompliance was issued for failure to meet the objective that each administration is in accordance with a written directive. The licensee responded in writing and no additional actions were required.
This event is closed for the purpose of this report.
Examples of Loss of Control of Material
1. Loss of Exit Signs Containing Tritium at Marlboro Psychiatric Hospital in Marlboro, New Jersey
This example is included in this report because of: (1) significant media interest; (2) pending legislation in the New Jersey Legislature on limiting the use of devices containing tritium; and (3) the U.S. Nuclear Regulatory Commission (NRC) staff's current work to develop rule-making for a registration program for certain types of NRC general licensees.
On February 26, 1998, Marlboro Psychiatric Hospital, a general licensee in Marlboro, New Jersey, discovered the loss of three exit signs containing approximately 1.85 terabecquerel (50 curie) of tritium. The licensee noted this loss during a routine, weekly visual inspection of two vacant cottages located on the hospital grounds. NRC conducted a safety inspection, which included confirmatory surveys of the vacant cottages from which the signs were missing. No contamination above the removable contamination criteria listed in the "Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source or Special Nuclear Material" was found. The hospital investigated the loss and searched the premises, but did not locate the signs. All remaining tritiated exit signs were removed from the Marlboro site and sent back to the manufacturer.
NRC conducted a safety inspection and is in the process of determining a final enforcement action.
2. Unauthorized Removal of Brachytherapy Sources from Moses Cone Health Systems, Inc., in Greensboro, North Carolina
This example is included in this report because of: (1) significant media interest; and (2) increased efforts from the North Carolina Division of Radiation Protection (NCDRP), NRC, the Department of Energy (DOE), and the Federal Bureau of Investigation (FBI), to locate the missing sources.
On March 4, 1998, the Radiation Safety Officer (RSO) at Moses Cone Health System, Inc., in Greensboro, North Carolina, during a quarterly physical inventory of sealed sources, noticed that the entire inventory of 18 cesium-137 (Cs-137) brachytherapy sources was missing from the locked storage safe (a "hot lab" within the Radiation Oncology Department). In addition to the 18 sources missing from the safe, a new Cs-137 source that was still in its shipping container was also missing. The activities of the sources ranged from 0.44 to 2.3 gigabequerel (GBq) [12-62 millicurie (mCi)]. The total activity missing from the facility was 22 GBq (604 mCi).
The RSO notified the NCDRP and reported that, although a hospital-wide search was underway, the sources had not been located. The NCDRP notified NRC and other Federal, State, and local officials to inform them about the incident. The NCDRP conducted its own investigation on March 5 and March 6, 1998, but did not locate the missing sources. The investigation efforts were repeated March 9-12, 1998, with no success.
On March 20, 1998, a joint effort by NCDRP, NRC, DOE, and FBI was undertaken. On March 24, 1998, after extensive searching for the missing sources, DOE terminated its effort. NCDRP is continuing the investigation and has not reached a final conclusion about the cause of this event. It is believed, however, that inadequate security contributed to the event. An information notice was sent to all medical licensees in North Carolina concerning this event.
The licensee has taken certain measures to prevent future incidents, including the installation of keypad entry systems for the physics laboratory and the "hot lab" door. The safe has been re-keyed and the key is under the direct control of the RSO at all times.
(Contact: Gary Purdy, NMSS, 301-415-7897; e-mail: firstname.lastname@example.org)
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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1. NRC had previously received an application from Northern States Power (NSP) for an away-from-reactor ISFSI for the storage of spent fuel from the Prairie Island Nuclear Generating Plant. However, this application was subsequently withdrawn by NSP before the staff's review had been completed.
2. Castle Rock recently requested that it be allowed to withdraw from the ASLB proceedings and that its contentions be dismissed. This request is currently pending ASLB review.