Spotlight
2011 Materials Actions
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Lincoln University of Missouri (EA-11-219)
On December 19, 2011, the NRC issued a Notice of Violation to Lincoln University of Missouri for a Severity Level III problem involving multiple violations of license conditions and NRC regulations. Specifically, the licensee failed to: (1) ensure that the individual named on the NRC license fulfilled the responsibilities of the RSO between May 2009 and August 18, 2011; (2) conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license between May 2009 and August 8, 2011; (3) notify the NRC in writing within 60 days of no longer conducting principal activities for a period of 24 months; (4) maintain records of receipt of radioactive materials for as long as the material was possessed as well as maintain disposal records until termination of the NRC license; and (5) comply with the applicable requirements for performing leak tests and inventories of generally licensed devices.
International Cyclotron, Inc. (EA-11-086)
On December 19, 2011, the NRC issued a Notice of Violation and Proposed Imposition of a Civil Penalty in the amount of $7000, and an Order suspending licensed activities within 60 days, to International Cyclotron, Inc. (ICI), for a Severity Level III violation of 10 CFR 30.35. The violation involved ICI’s failure to provide a decommissioning funding plan. Specifically, on August 20, 2009, ICI was issued an NRC license authorizing the possession and use of unsealed byproduct material of applicable quantities set forth in Appendix B to 10 CFR Part 30 and ICI has not provided a decommissioning funding plan that contains a signed original of the financial instrument obtained to provide financial assurance for decommissioning, as required by 10 CFR 30.35. Further, based on ICI’s failure to fully and timely respond to repeat NRC requests for information, and to compel ICI to comply with NRC regulations, the NRC issued an Order Suspending Licensed Activities (Order). According to this Order, if ICI does not submit to the NRC an acceptable financial assurance instrument within 60 days of the date of the Order, ICI is required to suspend all activities authorized under its License. This Order will remain in effect until ICI submits a financial assurance instrument and the NRC informs ICI that the instrument is accepted.
Cardinal Health PET Manufacturing Services, Inc. (EA-11-146)
On November 9, 2011, the NRC issued a Notice of Violation to Cardinal Health PET Manufacturing Services, Inc., for a Severity Level III violation involving the failure to monitor the occupational exposure to an adult who was likely to receive, in one year from sources external to the body, an extremity dose in excess of 5 rem as required by 10 CFR 20.1502(a)(1). Specifically, on June 16, 2010, a Cardinal Health PET Manufacturing Services employee removed his extremity (ring) dosimetry on two separate occasions prior to handling a chemical cartridge containing approximately 4 curies of fluorine-18.
Warner Brothers, LLC (EA-11-209)
On November 8, 2011, the NRC issued a Notice of Violation to Warner Brothers, LLC 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. Specifically, on December 6, 2006, and July 7, 2008, Warner Brothers LLC, which only holds a Massachusetts license, used a portable gauge containing a sealed source, at temporary jobsites within the State of Connecticut, without obtaining a specific license issued by the NRC or filing NRC Form-241 with the NRC, as required.
Escanaba Paper Company (EA-11-061)
On October 17, 2011, the NRC issued a Notice of Violation to Escanaba Paper Company for a Severity Level III violation involving the failure to ensure that only persons specifically licensed by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State perform services involving the dismantling and non-routine maintenance or repair of components related to the radiological safety of the gauge. Specifically, on May 9, 2011, the licensee performed non-routine maintenance on a fixed level gauge by using a rod to change the position of the shutter contrary to NRC License No. 21-17630-01, Condition 17.B. The licensee was not specifically licensed by the NRC or an Agreement State to perform this service.
Construction Testing and Engineering, Inc. (EA-11-071)
On September 26, 2011, the NRC issued a Notice of Violation (Notice) and Proposed Imposition of Civil Penalty in the amount of $1,750 to Construction Testing and Engineering, Inc. (CTE), for a Severity Level III violation. The violation involved the failure to maintain a minimum of two independent physical controls that formed a tangible barrier to secure a portable gauge from unauthorized removal during a period when the gauge was not under direct control or surveillance. Specifically, on October 26, 2010, CTE stored a portable gauge in its locked transport container, inside of the trunk of a vehicle at a temporary jobsite. The gauge was secured with only a single independent physical control (the lock to the trunk). The vehicle was stolen on that date and the gauge inside was removed from the storage location by defeating only one barrier. Additionally, the Notice issued 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. Specifically, between September 14, 2010, and October 26, 2010, CTE, which held a Virginia license, engaged in activities involving the use of a portable gauge containing sealed sources at a temporary site in District of Columbia, an area of exclusive federal jurisdiction without obtaining a specific license issued by the NRC or filing NRC Form-241 with the NRC, as required.
Associated Specialists, Inc. (EA-11-179)
On September 21, 2011, the NRC issued a Notice of Violation to Associated Specialists, Inc. (ASI), for a Severity Level III problem. The violations involved the licensee’s failure to: (1) limit operation with a temporary radiation safety officer (RSO) to a period of 60 days, in accordance with 10 CFR 35.24(c); and (2) ensure that its authorized user (AU) provided adequate supervision to licensee staff who were involved in the receipt, possession, use, transfer or preparation of byproduct material, in accordance with 10 CFR 35.27. Specifically, after ASI’s RSO left the company on June 8, 2010, the AU functioned as the temporary RSO until October 13, 2010, a period greater than 60 days. And from August 16, 2009 until April 19, 2011, the AU had limited oversight of the program, such that ASI personnel under the supervision of the AU had not spoken to him and had not received instructions associated with ASI’s written radiation protection procedures, NRC regulations, ASI’s license conditions, and the requirement that supervised individuals follow the instructions of the supervising authorized user for medical uses of byproduct material.
William Beaumont Hospital (EA-11-163)
On September 2, 2011, the NRC issued a Notice of Violation to William Beaumont Hospital for a Severity Level III violation involving the failure to develop written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, as of May 5, 2011, the licensee’s written procedures for yttrium-90 treatments did not specify how personnel should administer a treatment using a fine bore catheter and a high concentration of microspheres in order to prevent blockage within the catheter.
Crittenton Hospital (EA-11-165)
On September 2, 2011, the NRC issued a Notice of Violation to Crittenton Hospital for a Severity Level III violation involving the failure to develop written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, between September 2009 and January 2011, the licensee failed to address in its written procedure the need to verify that the step size used in the treatment plan was correctly translated into the high dose rate (HDR) remote afterloader unit. As a result, the device’s control unit default step size of 2.5 mm was used instead of the 5 mm used in the treatment planning system.
Carmeuse Lime, Inc. (EA-11-145)
On September 2, 2011, a Notice of Violation was issued to Carmeuse Lime, Inc., for a Severity Level III Problem involving three violations. The first violation involved the failure to have the individual specifically authorized by Condition 12.A of the license fulfill the duties and responsibilities as the Radiation Safety Officer (RSO). Specifically, the individual left the company in 2007, and the licensee failed to appoint a new RSO and amend its license. The second violation involved the failure to conduct a physical inventory every six months, or at other intervals approved by the NRC, to account for all sealed sources and/or devices received and possessed under the license as required by Condition 15 of the license. The third violation involved the failure to test each gauge for the proper operation of the on-off mechanism (shutter) and indicator, if any, at intervals not to exceed six months or at intervals specified in the certificate of registration as required by Condition 16.B of the license.
Professional Service Industries, Inc. (EA-10-161)
On August 18, 2011, the NRC issued an Immediately Effective Confirmatory Order to Professional Service Industries, Inc., confirming commitments reached as part of an alternative dispute resolution (ADR) mediation settlement agreement. The NRC identified eight apparent safety violations as well as apparent security-related violations involving the performance of industrial radiography in the Rock Springs, Wyoming, area. In addition, the NRC indicated that willfulness on the part of an office manager and a radiographer appeared to have been a factor in two of the apparent violations. PSI made no admission that they deliberately violated any NRC requirement. As part of the agreement, PSI agreed to take several corrective actions involving increased management oversight and individual accountability including, but not limited to: (1) developing and implementing a disciplinary program managed by the corporate staff that provides a graded approach for radiation safety and security infractions; (2) enhanced routine and refresher training for staff; (3) annual safety culture training for Radiation Safety Officers; (4) enhanced annual audits of the Radiation Safety Program; and (5) advance notification if PSI will be working in NRC jurisdiction under reciprocity. PSI also agreed that a Confirmatory Order with a Notice of Violation and $15,000 civil penalty would be issued in order to avoid further action by the NRC. Prior to any enforcement action by the NRC, the licensee voluntarily terminated its NRC license for radiography but maintains Agreement State licenses for radiography and an NRC license for other non-radiographic, regulated activities.
U. S. Department of the Army (EA-10-129)
On August 1, 2011, the NRC issued a Notice of Violation to the Department of the Army (Army) for a Severity Level III violation involving the failure to implement 10 CFR 40.3, "License Requirements." Specifically, from April 1978, when NRC license SUB-459 expired, to the present, the Army continued to possess depleted uranium (DU) associated with the Davy Crockett weapons system in the form of spent fragments of spotting rounds (obtained from 1962 to 1968, and expended prior to 1968) at firing ranges located at the Army's two installations in Hawaii, Schofield Barracks and Pohakuloa Training Area. In addition to the two installations in Hawaii, the Army has also identified the presence of spent DU spotting rounds at other Army installations across the United States.
On July 22, 2011, the NRC issued a Notice of Violation to Liberty Hospital for a Severity Level III violation involving the failure to develop written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, as of October 6, 2010, the licensee’s procedure did not require the position of the prostate to be verified prior to seed placement. As a result, the prostate received 16.9 Gray (Gy) as opposed to the prescribed dose of 125 Gy.
Bozeman Deaconess Hospital (EA-10-258)
On July 8, 2011, a Confirmatory Order (effective immediately) was issued to Bozeman Deaconess Hospital (BDH) to confirm commitments made as a result of an Alternative Dispute Resolution (ADR) settlement agreement. During inspection and investigation, NRC identified two willful violations. The violations involved the failures to secure licensed materials from unauthorized removal or access as required by 10 CFR 20.1801 and to control and maintain constant surveillance of licensed material as required by 10 CFR 20.1802. In response to these violations, the licensee requested ADR. BDH agreed to take a number of actions as part of this Confirmatory Order: providing training to hospital staff and managers involved in NRC licensed activities by an independent third-party organization; modifying the internal requirements for new worker training and for its annual refresher training; developing and implementing a procedure that allows hospital employees and contractors to raise radiation safety concerns to hospital management; and paying a civil penalty in the amount of $3,500.
Luzenac America, Inc. (EA-11-022)
On July 7, 2011, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $8,500 to Luzenac America, Inc., for a Severity Level III violation involving the failure to transfer a device containing byproduct material to a licensee authorized to receive it, as required by 10 CFR 31.5(c)(8)(i). Specifically, as of December 2, 2010, Luzenac transferred a fixed nuclear gauge containing byproduct material to a recycling company that was not authorized to receive it.
Charleston Radiation Therapy Consultants, PLLC (EA-11-115)
On June 30, 2011, the NRC issued a Notice of Violation to Charleston Radiation Therapy Consultants, PLLC (CRTC) for a Severity Level III violation involving the failure to meet the physical presence requirements of 10 CFR 35.615(f)(2) during high dose radiation (HDR) treatments. Specifically, on an indeterminate number of occasions on and prior to April 28, 2011, neither a CRTC authorized user (AU), nor a physician under the supervision of an AU, was physically present during continuation of patient treatments involving the HDR unit.
Henry Ford Macomb Hospital (EA-11-088)
On June 24, 2011, the NRC issued a Notice of Violation to Henry Ford Macomb Hospital for a Severity Level III violation involving the failure to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, as of December 9, 2010, the licensee’s procedure did not include steps to verify that the transfer tube assembly used at the time of the administration was the same length as the one identified in the treatment plan implementing the written directive. This resulted in four patients receiving radiation doses to areas not included within the planned treatment area.
Owensby and Kritikos, Inc. (EA-11-100)
On June 8, 2011, the NRC issued a Notice of Violation to the Owensby and Kritikos, Inc., for a Severity Level III violation involving the licensee’s failure to control and maintain constant surveillance of the licensed material in an unrestricted area as required by 10 CFR 20.1801 and 20.1802. Specifically, during inspection on July 29, 2010, the radiography camera was found on the floor of the unlocked darkroom and no radiography personnel were maintaining constant surveillance over the material.
On June 8, 2011, the NRC issued a Notice of Violation to Mercy Hospital for a Severity Level III violation involving the failure to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, between June 18, 2008 and February 23, 2011, the licensee performed approximately 200 high dose-rate (HDR) remote afterloader administrations requiring written directives, and failed to develop written procedures to provide high confidence that each administration was in accordance with the written directive.
Alaska Industrial X-Ray, Inc. (EA-10-231)
On June 7, 2011, a Confirmatory Order (effective immediately) was issued to Alaska Industrial X-Ray Inc. (AIX) to confirm commitments made as a result of an Alternative Dispute Resolution (ADR) settlement agreement. During inspection and investigation, NRC identified a deliberate violation associated with two conditions of the Order Modifying License (EA-08-196): (1) failure to have an independent consultant or contractor perform field audits and submit the audit reports to AIX, and the NRC, as required by Condition 1 of the Order, from August 2008 through March 2010 and (2) failure to have an independent consultant or a contractor evaluate the effectiveness of AIX’s radiation safety program, as required by Condition 3 of the Order, from September 2008 through October 2010. In response to these violations, the licensee requested ADR. As part of the agreement, AIX agreed to take a number of actions including training for all AIX employees engaged in licensed activities on what is meant by willfulness, conducting an annual review of its radiation safety and compliance program by an independent auditor, conducting quarterly audits of AIX radiographers as they perform radiography, and paying a civil penalty in the amount of $1,000.
Providence Hospital (EA-11-037)
On May 17, 2011, the NRC issued a Notice of Violation to Providence Hospital for a Severity Level III violation involving the failure to develop written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, as of August 30, 2010, the licensee’s brachytherapy procedure did not provide high confidence that the needles would be inserted to the right depth as the licensee did not require the use of available means such as biological or needle markers.
On May 11, 2011, the NRC issued a Notice of Violation to Del Valle Group (DVG) for a Severity Level III violation involving the failure to obtain authorization in a specific NRC license to own and possess three portable moisture density gauges, as required by 10 CFR 30.3(a). Specifically, from November 30, 2008 through October 28, 2010, DVG owned and/or possessed byproduct material (discrete radium-226 sources contained in three portable moisture density gauges) without authorization in a specific or general license issued in accordance with NRC regulations.
Community Hospitals of Indiana (EA-11-016)
On April 20, 2011, the NRC issued a Notice of Violation to the Community Hospitals of Indiana for a Severity Level III violation involving the failure to fully implement procedures to provide high confidence that a brachytherapy treatment was in accordance with the written directive as required by 10 CFR 35.41(a). Specifically, on September 30, 2010, an authorized medical physicist missed a step in the procedure that established the starting position for the high dose remote afterloader brachytherapy treatment. The failure to implement this step resulted in a medical event.
West Virginia University Hospitals, Inc. (EA-11-027)
On March 25, 2011, the NRC issued a Notice of Violation to West Virginia University Hospitals Inc. (WVUH) for a Severity Level III violation involving the failure to notify the NRC Operations Center by telephone no later than the next calendar day after discovery of the medical event as required by 10 CFR 35.3045(c). Specifically, WVUH did not notify the NRC until July 7, 2010, after discovering that a dose administered on January 20, 2010 differed from the prescribed dose.
Oakwood Hospital - Annapolis Center (EA-11-010)
On March 4, 2011, the NRC issued a Notice of Violation to Oakwood Hospital – Annapolis Center for a Severity Level III problem involving: (1) the licensee’s usage of a dose that differed from the prescribed dose by more than 20 percent which is contrary to 10 CFR 35.63(d); and (2) the failure to verify that the assayed dosage was within 10 percent of the prescribed activity as required by License Condition 15.A. Specifically, the licensee administered approximately 124.5 millicuries of sodium pertechnetate technetium-99m (Tc-99m) to a patient instead of the prescribed dosage of 10 millicuries of Tc-99m tetrofosmin, a difference in excess of 20 percent. The licensee failed to verify that it had the correct syringe which resulted in the incorrect radiopharmaceutical and dosage being administered to the patient.
Mattingly Testing Services, Inc. (EA-10-100)
On February 22, 2011, the NRC ASLB Hearing Board issued a Memorandum and Order accepting a Settlement and Dismissing the Hearing Proceeding in the matters of Mattingly Testing Services, Inc., (MTS) Order Revoking License (EA-10-100) and Mark M. Ficek Order Prohibiting Engagement in NRC-licensed Activities (IA-10-028) that were both issued on September 2, 2010. Specifically, the NRC staff and two parties, employees of MTS, who had requested a hearing on the September 2 Orders had agreed to a settlement on February 4, 2011, in lieu of continuing the hearing proceeding. The Settlement Agreement was forwarded to the ASLB and approved. The February 22, 2011 Board Order superseded the September 2, 2010 Order Revoking License issued to MTS and the Order Prohibiting Engagement in NRC-licensed Activities issued to Mark M. Ficek. The Order and Settlement included the following terms and conditions: (1) the MTS license remains revoked and parties agree that it will not be reinstated; (2) Mr. Ficek is prohibited from engaging in NRC-licensed activities until September 2, 2017 (the settlement further defines NRC-licensed activities); (3) for a three year period after September 2, 2017, Mr. Ficek is required to notify NRC of employment involving NRC-licensed activities; (4) Mr. Ficek is allowed non-controlling ownership in an NRC licensee, subject to conditions specified in the settlement prohibiting Mr. Ficek’s engagement in licensed activities; (5) Mr. Ficek is allowed to own and/or sell the radiographic exposure devices that were listed on the former MTS license, subject to conditions specified in the settlement; and, (6) that all parties agree that all further procedural steps before the ASLB and any right to challenge or contest the validity of the Board Order entered into in accordance with the Settlement Agreement, and all rights to seek judicial review or otherwise contest the validity of the Board Order are expressly waived.
Bristol Hospital, Inc. (EA-11-008)
On February 17, 2011, the NRC issued a Notice of Violation to Bristol Hospital, Inc. for a Severity Level III violation involving the failure to notify the NRC Operations Center of two medical events, in accordance with 10 CFR 35.3045(c), which requires a report within the next calendar day of discovery. Specifically, on January 12, 2010, Bristol Hospital experienced two medical events involving patients receiving less than the intended prescribed dose during two different permanent prostrate brachytherapy seed implants. The administered doses differed from the prescribed doses by 50 rem to an organ or tissue, and the total doses differed by greater than 20 percent from the prescribed doses. As of March 1, 2010, Bristol Hospital personnel had information available to determine that these medical events had occurred on January 12, 2010, and should have therefore reported the events by March 2, 2010. However, the licensee did not verbally report the events to the NRC until June 2, 1010 following NRC questioning of the circumstances during an inspection.
Carro & Carro Enterprises, Inc. (EA-10-272)
On February 11, 2011, the NRC issued a Notice of Violation to Carro & Carro Enterprises, Inc. (CCE) for a severity level III violation involved CCE’s failure to obtain authorization in a specific NRC license to own and possess the portable moisture density gauge, which contained byproduct material. Specifically, from November 30, 2008, through June 28, 2009, CCE owned and/or possessed byproduct material, a discrete radium-226 source contained in a portable moisture density gauge, without authorization in a specific or general license issued in accordance with NRC regulations.
Superior Well Services, Ltd. (EA-10-077)
On February 8, 2011, the NRC issued an Immediately Effective Confirmatory Order to the Superior Well Services, Ltd. (SWS) to confirm commitments made as a result of an Alternate Dispute Resolution (ADR) mediation session held on January 4, 2011. The licensee requested ADR following the NRC’s October 21, 2010, Notice of Violation and Proposed civil penalty of $34,000, for five violations that were categorized into two severity level (SL) III problems. The first SL III problem involved three violations related to the temporary loss of two radioactive well logging sources. The second SL III problem involved two violations related to the deliberate failure to conduct radiological surveys and the creation of inaccurate survey records. As part of the agreement, SWS took number of actions addressing all of the violations, to ensure that the corrective actions are effective, and to ensure that lessons learned from these events are extended to the well logging industry. In addition, SWS took several corrective actions prior to the ADR mediation session. In recognition of SWS’s proposed extensive corrective actions, in addition to corrective actions already taken, the NRC agreed to reduce the civil penalty originally proposed to $17,000.
