United States Nuclear Regulatory Commission - Protecting People and the Environment

2012 Materials Actions

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Lakeland Medical Center (EA-12-202)

On December 6, 2012, a Notice of Violation was issued to Lakeland Medical Center for a Severity Level III violation involving the failure to ensure that a written directive to administer I-131 sodium iodide greater than 30 microcuries was signed by an authorized user as required by 10 CFR 35.40(a). Specifically, on three separate occasions, one each on February 28, February 29, and March 20, 2012, 2-milicurie diagnostic dosages of I-131 sodium iodide were administered and the individual that signed the written directives was not listed as an authorized user.

Cambridge Isotope Laboratories, Inc. (EA-12-177)

On October 31, 2012, the NRC issued a Severity Level III Notice of Violation (NOV) to Cambridge Isotope Laboratories (CIL) for violations of 10 CFR 110.20, “General license information,” and 10 CFR 110.24, “General license for the export of deuterium.” Between 2007 and 2011, CIL failed to file an application with the Commission for specific export licenses to export deuterium, a material subject to NRC licensing jurisdiction in accordance with 10 CFR 110.9 when exporting this material in excess of the quantities covered by the general license requirements of 10 CFR 110.24. During this time, CIL exported deuterium (1) in excess of the 200 kilogram (kg)/year limit set by 10 CFR 110.24(a) to China and Japan in the years 2010 and 2011, and (2) in excess of the 5 kg/year limit set by 10 CFR 110.24(b) to restricted destinations per 10 CFR 110.29, India and Israel, in the years 2007-2011, without applying for and obtaining NRC specific licenses.

Detector Electronics Corporation (EA-12-181)

On October 19, 2012, the NRC issued a Notice of Violation to Detector Electronics Corporation for a Severity Level III violation involving the failure to obtain a specific authorization to export byproduct material to Iraq, an embargoed country, as required by CFR 110.5. Specifically, on April 20, 2007, September 25, 2009, December 21, 2010, and June 24, 2011, the licensee exported flame detectors with electron tubes containing krypton-85 to Iraq, an embargoed destination and did not have a required specific authorization to export byproduct material to Iraq.

St. John Macomb-Oakland Hospital (EA-12-172)

On October 16, 2012, the NRC issued a Notice of Violation to St. John Macomb-Oakland Hospital for a Severity Level III violation involving the failure to have written procedures in place that would provide high confidence that each high dose-rate remote afterloader (HDR) brachytherapy administration was in accordance with the written directive as required by 10 CFR Part 35.41(a). Specifically, on July 9, 2012, the licensee's written procedures failed to ensure that the patient's endobronchial catheters were directly connected to the HDR unit such that the brachytherapy administration would occur in accordance with the written directive.

DBI, Inc. (EA-12-058)

On October 11, 2012, the NRC issued a Confirmatory Order (Effective Immediately) to DBI, Inc. to formalize commitments made as a result of an ADR mediation session held on September 6, 2012. The commitments were made as part of a settlement agreement regarding apparent violations identified during an inspection and investigation involving the failure to: (1) conduct a survey when approaching the radiography camera and guide tube; (2) have at least one other qualified individual present while performing radiography; (3) supervise the assistant radiographer; and (4) provide complete and accurate information to the Commission. DBI, Inc. agreed to a number of corrective actions, including paying a civil penalty of $3,500, making improvements to operating and emergency procedures, and conducting employee training on the importance of complying with NRC regulations including examples of willful violations.

Avera McKennan Hospital (EA-12-090)

On October 3, 2012, an NOV and Proposed Imposition of a Civil Penalty in the amount of $11,200 was issued to Avera McKennan Hospital for a SL II violation involving the failure to maintain written procedures to provide high confidence that each treatment is in accordance with the physician’s written directive as required by 10 CFR 35.41. Specifically, on January 16 and 17, 2012, procedures related to high dose-rate remote afterloader treatments failed to 1) verify a brachytherapy treatment was in accordance with the treatment plan and written directive as required by 10 CFR 35.41(b)(2); 2) check both manual and computer-generated dose calculations as required by 10 CFR 35.41(b)(3); and (3) verify that any computer-generated dose calculations were correctly transferred into the consoles of therapeutic medical units as required by 10 CFR 35.41(b)(4). This violation was repeated, resulting in radiation underexposures to the intended treatment site and exposures to an unintended site on two consecutive days. As a result of the licensee’s performance, the NRC used enforcement discretion in accordance with Section 3.6 of the Enforcement Policy to double the base civil penalty for a SLII violation.

The Christ Hospital (EA-12-142)

On August 28, 2012, the NRC issued a Notice of Violation to The Christ Hospital, for a Severity Level III violation involving the failure to file NRC Form 241 “Report of Proposed Activities in Non-Agreement States,” at least three days prior to engaging in licensed activities within NRC jurisdiction, as required by 10 CFR 150.20 (b).  Specifically, on multiple occasions between January 2009 and March 8, 2012, The Christ Hospital - Mobile, a licensee of the State of Ohio, possessed and used syringes containing technetium-99m at a temporary job site in Indiana, a non-Agreement State, without first filing a Form-241 with the NRC, at least three days before engaging in such activity.

Quality Inspection and Testing, Inc. (EA-11-124)

On August 10, 2012, the NRC issued a Confirmatory Order (Effective Immediately) to Quality Inspection and Testing, Inc. (QIT) to formalize commitments made as a result of an ADR mediation session. The commitments were made by QIT as part of a settlement agreement between QIT and the NRC regarding apparent violations of NRC requirements by the lead radiographer and the radiographer’s assistant. The agreement resolves the apparent violations that were identified during NRC inspection and investigation and involve QIT’s failure to comply with requirements including: maintaining control and constant surveillance of licensed material that is not in storage (10 CFR 20.1802); wearing a direct reading dosimeter, alarm ratemeter, and personnel dosimeter while conducting radiographic operations (10 CFR 34.47); and maintaining records and documents (10 CFR 34.89). QIT agreed to a number of additional corrective actions beyond actions taken, including such areas as: (1) issuance of a policy statement addressing each of the areas of violation; (2) issuance of a letter from the QIT president regarding compliance and communicating concerns to management; (3) enhancing their training program; (4) submitting a number of procedures for NRC review and approval, such as management oversight and reporting concerns; and (5) presenting a paper for a professional society meeting. Additionally, QIT agreed to pay a civil penalty in the amount of $3,500.

MedStar Georgetown Medical Center (EA-12-085)

On August 3, 2012, the NRC issued a Notice of Violation to the Medstar Georgetown Medical Center (MGMC), for a Severity Level III violation involving the licensee’s failure to control and maintain constant surveillance of the licensed material in a controlled area as required by 10 CFR 20.1802.  Specifically, between December 13 and 14, 2011, MGMC did not control and maintain constant surveillance of licensed material that was in an unsecured lead shielded container, in the high dose-rate remote afterloader (HDR) Procedure Room, a controlled area, for approximately 24-30 hours. 

L.E. Gregg Associates (EA-12-108)

On July 27, 2012, the NRC issued a Notice of Violation to L.E. Gregg Associates for a Severity Level III violation. The violation involved a failure to file NRC Form 241 “Report of Proposed Activities in Non-Agreement States,” at least three days prior to engaging in licensed activities within NRC jurisdiction, as required by 10 CFR 150.20(b).  Specifically, on December 12-16, 2011, January 5-7, 2012, and February 21-24, 2012, L.E. Gregg Associates, which only holds a Kentucky (Agreement State) license, used and stored a portable nuclear gauge at temporary jobsites in West Virginia (non-Agreement State), without obtaining a specific license issued by the NRC or filing NRC Form-241, at least three days before engaging in such activity.

Gamma Irradiator Services (EA-12-088)

On July 11, 2012, the NRC issued a Notice of Violation to Gamma Irradiator Services (GIS) for a Severity Level III violation. The violation involved the failure to limit licensed activities to Category 1 self-shielded irradiators, as required by Condition 9 of GIS's NRC license No. 37-30850-01. Specifically, on May 2, 2003, February 25, 2005, June 15, 2007, and May 19, 2009, GIS performed maintenance activities on a JL Shepherd Model 81-22 irradiator, which is not a self-shielded (Category I) irradiator but, rather, a panoramic (Category II) irradiator.

United States Air Force (Wright Patterson Medical Center) (EA-12-031)

On June 29, 2012, the NRC issued a Notice Violation and Proposed Imposition of a Civil Penalty in the amount of $8,500 to the United States Air Force (USAF) for a Severity Level (SL) III problem. The SL III problem involved two violations: 1) the USAF’s failure to conduct a semiannual physical inventory of all sealed sources in their possession, as required by 10 CFR 35.67(g); and 2) the USAF’s failure to secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas, as required by 10 CFR 20.1801. Specifically, between November 2, 2004 and September 30, 2011, the USAF did not include a sealed source, which was believed to be in storage, in its semiannual physical inventory. The USAF believed the source was located in the low-level radioactive waste storage room, which is a controlled area; however, sometime between November 2, 2004, when the last physical inventory occurred, and September 30th 2011, the source was lost.

American Radiolabeled Chemicals (EA-12-077)

On June 25, 2012, the NRC issued a Notice of Violation to American Radiolabeled Chemicals for a Severity Level III violation involving the failure to implement 10 CFR 20.1801.  Specifically, on April 2, 2012 the licensee failed to secure from unauthorized removal or limit access to licensed material stored in a controlled area.

neo-pet, LLC (EA-12-068)

On June 13, 2012, the NRC issued a Notice of Violation to neo-pet, LLC, a licensee of the State of Ohio, for a Severity Level III violation involving 10 CFR 150.20.  Specifically, on multiple occasions between April 6, 2010, and March 6, 2012, neo-pet, LLC, possessed and used doses of fluorine-18 in Indiana, a Non-Agreement State, without filing an NRC Form 241 at least three days prior to engaging in licensed activities in areas of exclusive Federal jurisdiction.

Texas Gamma Ray, LLC (EA-10-102)

On May 15, 2012, the NRC issued a Confirmatory Order (Effective Immediately) to Texas Gamma Ray, LLC (TGR) to formalize commitments made as a result of an ADR mediation session held on April 23, 2012.  The commitments were made as part of a settlement agreement between TGR and the NRC regarding apparent violations of NRC requirements.  The agreement resolves the apparent violations involving TGR’s failure to: (1) meet two NRC security requirements; and (2) store radioactive material only at a location authorized by its license.  Specifically, radioactive material was stored at a facility in Rock Springs, Wyoming, which was not an approved storage location.  TGR agreed to a number of corrective actions, including paying a civil penalty of $7,000, retrieving the licensed material from Wyoming and transferring it to a site in Texas authorized for storage, revising internal procedures, requiring the RSO’s approval for storing licensed material, and training all radiographers on the new procedures.

Flowserve Corporation (EA-12-060)

On April 30, 2012, the NRC issued a Notice of Violation to Flowserve Corporation for a Severity Level III violation. The violation involved a failure to obtain a specific license for export of reactor components, as required by 10 CFR 110.20. Specifically, in March 2010, Flowserve exported two reactor recirculation pump seal-repair kits, components subject to NRC licensing jurisdiction, to Mexico without obtaining an NRC specific license.

Advanced Material Services (EA-11-276)

On April 17, 2012, the NRC issued a Notice of Violation to Advanced Material Services, LLC (AMS) for a Severity Level III violation. The violation involved a failure to file NRC Form 241 “Report of Proposed Activities in Non-Agreement States,” at least three days prior to engaging in licensed activities within NRC jurisdiction, as required by 10 CFR 150.20(b). Specifically, between May 12 and June 26, 2008, AMS, which only holds an Alabama (Agreement State) license, used a portable nuclear gauge, at temporary jobsites within the State of Connecticut (non-Agreement state), without obtaining a specific license issued by the NRC or filing NRC Form-241, at least three days before engaging in such activity.

Morpho Detection, Inc. (EA-11-270)

On April 10, 2012, the NRC issued a Notice of Violation to Morpho Detection, Inc. (MDI), for a Severity Level III problem. The violations involved the licensee’s failure to: 1) file NRC Form 241 “Report of Proposed Activities in Non-Agreement States,” at least three days prior to engaging in licensed activities within NRC jurisdiction, as required by 10 CFR 150.20(b); and 2) store and use the byproduct material under a Agreement State license for a period of less than 180 days in a calendar year, as required by 10 CFR 150.20(b)(4). Specifically, between 2007 and 2011, on multiple occasions, MDI, a Massachusetts Agreement State license, engaged in activities in non-agreement states without obtaining a specific license issued by the NRC or filing NRC Form-241 as required. In addition, the material was stored and used in non-agreement states for periods greater than 180 days in any calendar year.

Department of the Army (EA-12-014)

On April 5, 2012, the NRC issued a Notice of Violation to the Department of the Army (Army), for a Severity Level III violation. The violation involved Army’s failure to provide a radiation monitor that was equipped with personnel access door locks to prevent access to the radiation room of the panoramic irradiator at the Redstone Arsenal facility, when radiation levels were high, as required by 10 CFR 36.23(c). Specifically, from September 24, 1996 to February 17, 2012, the Army’s radiation room personnel access door was not integrated with the radiation monitor to prevent the door from opening when radiation levels were high.

InstroTek, Inc. (EA-11-242)

On March 30, 2012, the NRC issued a Notice of Violation to InstroTek/CPN International (CPN) for a Severity Level III problem. The violations involved licensee’s failure to: 1) obtain a specific license to export byproduct materials to embargoed destinations as required by 10 CFR110.5; and 2) submit annual reports of americium exports as required by 10 CFR110.23(b) (currently 110.54(b)). Specifically, on November 20, 2008, and May 5, 2010, CPN exported americium-241 and cesium-137 byproduct materials subject to NRC licensing jurisdiction, to embargoed destinations (Iraq and Sudan), without a specific license as required. Also between 2000 and 2009, CPN exported americium and failed to file the required annual reports.

Humboldt Scientific, Inc. (EA-11-138)

On March 8, 2012, the NRC issued a Notice of Violation to Humboldt Scientific, Inc. (HSI) for a Severity Level III problem.  The violations involved a failure to obtain appropriate license authorization to export byproduct materials to embargoed destinations and a failure to submit annual reports of americium exports in accordance with 10 CFR 110.54(b). Specifically, on May 6, 2005, May 7, 2008, June 26, 2008, and July 31, 2008, HSI exported americium-241 and cesium-137 byproduct materials subject to NRC licensing jurisdiction, to embargoed destinations of Iraq and Sudan respectively, without a specific license as required by 10 CFR 110.5 and HSI failed to make annual reports of americium exports for calendar years 2000-2009, during which years americium exports were performed.

Dakota Panel (EA-11-233)

On February 7, 2012, the NRC issued a Notice of Violation to Dakota Panel for a Severity Level III violation involving the licensee's failure to identifying an individual as the Radiation Safety Officer (RSO) on its license, as required by License Condition 12. Specifically, from January 2010 until September 23, 2011, the licensee failed to have an individual named on its license in the RSO position or any qualified individual as RSO.

Roxar Flow Measurement, Inc. (EA-09-328)

On February 2, 2012, the NRC issued a Notice of Violation to Roxar Flow Measurement, Inc., for a Severity Level III violation involving the failure to only transfer byproduct material to persons authorized to receive such byproduct material in accordance with 10 CFR 30.41(a) and (b)(5). Specifically, on numerous occasions between September 2003 and August 2007, the licensee transferred fixed gauges containing byproduct material to persons not authorized to receive byproduct material under the terms of a specific license or a general license issued by the Commission or an Agreement State.

S&R Engineering S.E. (EA-11-098)

On January 13, 2012, the NRC issued a Notice of Violation and Proposed Imposition of a Civil Penalty in the amount of $14,000 to S&R Engineering (S&R) for a Severity Level (SL) III problem and two SL III violations. The SL III problem involved two violations: 1) S&R’s failure to comply with or respond to an NRC Order, as required by 10 CFR 2.202(b); and 2) S&R provided information to the NRC that was not complete and accurate in all material respects as required by 10 CFR 30.9(a). Specifically, as of January 13, 2012, S&R has not submitted an answer to the order (which was required by November 28, 2009), has not paid the license fee, and has not disposed of or transferred its licensed nuclear material to an authorized recipient. On August 3, 2010, the S&R president informed the NRC that S&R had transferred its portable moisture density gauge containing radioactive sources to another NRC licensee when S&R still possessed the gauge. The two additional SL III violations involved S&R’s failure to afford the NRC an opportunity to inspect materials, activities, and records under the regulations as required by 10 CFR 19.14(a) and S&R’s failure to use a minimum of two independent controls that form tangible barriers to secure portable gauge from unauthorized removal, when the portable gauge was not under S&R’s direct control and constant surveillance as required by 10 CFR 30.34(i). Specifically, on August 3, 2010, S&R provided the NRC inaccurate information about the location of its licensed material, thereby preventing inspection of S&R’s licensed activities and the gauge has been stored inside of its shipping case, which was located in an unlocked closet of the locked S&R office, providing only one barrier.

Universal Product Concepts, Inc. (EA-11-222)

On January 9, 2012, the NRC issued a Notice of Violation and Proposed Imposition of a Civil Penalty in the amount of $7,000.00, to Universal Product Concepts, Inc. (UPC) for a Severity Level III problem.  The violations involved a willful transfer of smoke detectors containing byproduct material (americium-241) without the NRC license as required by 10 CFR 30.3(a) and an import of material into United States without having the required license for possession of the material as required by 10 CFR 110.5.  Specifically, from May to July 2010, UPC imported and transferred approximately 19,423 smoke detectors containing byproduct material without the required NRC licenses authorizing such imports and transfers.

Regents of the University of Michigan (EA-11-228)

On January 6, 2012, the NRC issued a Notice of Violation to the Regents of the University of Michigan for a Severity Level III violation involving the failure to develop, implement, and maintain written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). In accordance with 10 CFR 35.41(b)(2), the procedures required by 10 CFR 35.41(a) must address verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive. Specifically, on March 9, 2011, the licensee administered a yttrium-90 TheraSphere™ liver treatment, but the licensee’s procedures did not require verifying that the administration of byproduct material was in accordance with the applicable treatment plan and written directive.

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Page Last Reviewed/Updated Friday, July 12, 2013