Spotlight
2010 Materials Actions
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Sanford Medical Center (EA-10-182)
On December 10, 2010, the NRC issued a Notice of Violation to Sanford Medical Center for a Severity Level III violation involving the failure to secure the high dose-rate remote (HDR) afterloader brachytherapy unit in accordance with License Condition 19.A and Section 3.3.1.1 of Standard Operating Procedure, NM-X2, “Radiation Safety Procedures for the Nucletron Microselectron HDR, Version 2.” Specifically, on June 15 through July 29, 2010, the licensee failed to secure the HDR afterloader unit from unauthorized removal or access from its storage area when the unit was not in use because a mechanical locking mechanism failed to function as designed, leaving the unit unsecured.
On December 2, 2010, the NRC issued a Notice of Violation and a Confirmatory Order to AREVA NP, Inc., as a result of an Alternate Dispute Resolution settlement for a violation of 10 CFR 71.5(a) and 49 CFR 172.204(a) involving inaccurate transportation records for several export shipments of special nuclear material (SNM). Specifically, on December 9, 2009, and March 11 and 18, 2009, an AREVA employee deliberately altered (falsified) the reference and date stamp on three documents entitled “Approval to Transit a UK [United Kingdom] Port” associated with the export of SNM from the United States to Germany by Areva NP, Inc.
St. Francis Hospital and Medical Center (EA-10-171)
On November 10, 2010, the NRC issued a Notice of Violation to St. Francis Hospital and Medical Center (St. Francis) 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 July 1, 2010 and other occasions prior to that date, a St. Francis authorized medical physicist was not physically present during initiation and continuation of patient treatments involving the HDR unit.
Walter Reed Army Medical Center (EA-10-140)
On October 25, 2010, the NRC issued a Notice of Violation to the Walter Reed Army Medical Center (WRAMC), for a Severity Level III problem. The violations involved the licensee’s failure to control and maintain constant surveillance of the licensed material in an unrestricted area as required by 10 CFR 20.1802 and failure to conduct operations so that the dose in any unrestricted area from external sources did not exceed 0.002 rem (0.02 millisievert) in any one hour. Specifically, between May 1 and 3, 2010, WRAMC did not control and maintain constant surveillance of packages containing licensed radioactive materials, which were improperly stored by WRAMC personnel in an unrestricted area under a counter in the concierge workstation, resulting in a dose greater than 0.002 rem in any one hour within the first floor lobby of the WRAMC.
Superior Well Services, Ltd. (EA-10-077)
On October 21, 2010, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $34,000 to the Superior Well Services, Ltd. (SWS), for two Severity Level III problems. The violations involved the licensee’s failure to: (1) secure a shipment of radioactive materials on a public highway to prevent shifting during normal transportation conditions in accordance with 10 CFR 71.5(a); control and maintain constant surveillance of the licensed material in an unrestricted area as required by 10 CFR 20.1802; and notify the NRC of the missing licensed material in accordance with 10 CFR 20.2201(a); (2) conduct required radiological surveys of vehicles before transporting licensed material in accordance with10 CFR 39.67, and the deliberate falsification of survey records for the vehicles. Specifically, on September 20, 2008, while transporting licensed material on a public highway, SWS did not secure a shipment of radioactive materials, and failed to control and maintain constant surveillance of the licensed material for at least ninety minutes, until SWS located and retrieved the sources, and also failed to notify the NRC of the missing licensed material until July 23, 2009, ten months after identifying the event. In addition, on an unspecified number of occasions prior to July 22, 2010, before transporting licensed materials, SWS did not make radiation surveys of the position occupied by each individual in the vehicle and of the exterior of the vehicle used to transport the licensed materials and recorded survey results that were obtained by copying from previous survey records.
Analytical Bio-Chemistry Laboratories, Inc. (EA-10-135)
On October 13, 2010, the NRC issued a Notice of Violation to Analytical Bio-Chemistry Laboratories, Inc., for a Severity Level III problem involving two violations. The first violation involves the failure to notify the NRC in writing within 60 days of the decision to permanently cease principal activities in any separate building that contains residual radioactivity and is unsuitable for release as required by 10 CFR 30.36(d)(2). Specifically, as of February 2010, the licensee decided to permanently cease principal activities in two buildings that contained residual radioactivity, and the NRC was not notified until June 30, 2010, and July 14, 2010. The second violation involves the failure to submit a decommissioning plan and receive NRC approval of procedures used in aggressive remediation activities as required by 10 CFR 30.36(g). Specifically, on June 22, 2010, the licensee demolished and removed contaminated countertops, floors, and fume hoods with associated ventilation ducts. These types of activities involved techniques not routinely applied during cleanup or maintenance operations such that there was the potential for health and safety impacts to the workers.
McConnell Dowell (American Samoa), Ltd. (EA-10-174)
On October 6, 2010, the NRC issued a Notice of Violation to McConnell Dowell (American Samoa), Ltd., for a Severity Level III violation involving the receipt, possession, and usage of byproduct material without authorization from a specific or general license as required by 10 CFR 30.3(a). Specifically, as early as 2008 to July 25, 2010, the licensee received, possessed and used two portable nuclear gauges in American Samoa, an area of exclusive Federal jurisdiction, without a specific license issued by the U.S. Nuclear Regulatory Commission.
Mattingly Testing Services, Inc. (EA-10-100)
On September 2, 2010, the NRC issued an Order Revoking License (Immediately Effective) to Mattingly Testing Services, Inc., for multiple violations of NRC requirements. Specifically, (1) on various dates beginning on May 3, 2009, the licensee, in part deliberately, failed to implement specified actions required by Confirmatory Order (EA-08-271) involving: (i) conducting an assessment of the radiation safety program, (ii) providing initial safety training to the licensee staff, (iii) ensuring that an independent consultant’s recommended program improvements were provided within 30 days of completing the required reviews, (iv) providing the independent consultant’s 2009 annual audit results to the NRC, (v) conducting the initial field audit of radiography operations by the independent consultant by May 3, 2009, and (vi) submitting a required license amendment request by May 3, 2009; (2) from May 13, 2006 through September 9, 2009, the licensee deliberately failed to establish and maintain a prearranged response plan with the Local Law Enforcement Agency (LLEA) in accordance with Increased Controls Order (EA-05-090), Attachment B, Section IC-2(b); (3) on March 6, 2007, the licensee president deliberately failed to provide complete and accurate information to an NRC inspector in accordance 10 CFR 30.9, regarding the licensee’s effort to establish a prearranged response plan with the LLEA; (4) on October 22, 2009, while under oath, the licensee president deliberately failed to provide complete and accurate information to an NRC investigator in accordance with 10 CFR 30.9 regarding the licensee’s effort to establish a prearranged response plan with the LLEA; (5) on July 4, 16, and August 29-30, 2009, the licensee failed to maintain a dependable means to detect, assess, and respond to unauthorized access to radioactive materials in accordance with Increased Controls Order (EA-05-090) Appendix B, Section IC-2(c); (6) on June 22, 2009, the licensee failed to properly secure a radiographic exposure device for transport with proper blocking and bracing to prevent loss during transit in accordance with 10 CFR 20.1802, 10 CFR 34.35(d), and 10 CFR 71.5 that led to the device being lost in the public domain; and, (7) on June 22, 2009, the licensee willfully failed to immediately notify the NRC about the lost radiographic exposure device in accordance with 10 CFR 20.2201.
St. Louis Testing Laboratories, Inc. (EA-10-085)
On August 31, 2010, the NRC issued a Notice of Violation to St. Louis Testing Laboratories, Inc., for a Severity Level III violation involving the failure to ensure each individual who acts as a radiographer or a radiographer's assistant wears a direct reading dosimeter, an operating alarm rate meter, and a personal dosimeter at all times during radiographic operations as required by 10 CFR 34.47(a). Specifically, on October 22, 2009, a radiographer inadvertently left his personal dosimeter in a tool bag inside a permanent radiographic cell while performing radiographic shots.
Universal Engineering Sciences, Inc. (EA-10-138)
On August 27, 2010, the NRC issued a Notice of Violation to Universal Engineering Sciences, Inc. (UES), 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, UES used portable gauges containing sealed sources, at numerous areas of exclusive federal jurisdiction within the States of Florida and Georgia, without obtaining a specific license issued by the NRC or filing NRC Form-241 with the NRC, as required.
Basin Electric Power Cooperative (EA-09-258)
On August 26, 2010, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $24,700 to Basin Electric Power Cooperative. The violations involved: (1) Severity Level (SL) II violation of 10 CFR 20.1301(a)(1) for failure to limit radiation exposure to members of the public to less than 100 millirem in a year, resulting in six members of the public received doses in excess of 100 millirem; (2) SL III violation of 10 CFR 20.1902(e) for failure to conspicuously post caution signs with the words “CAUTION, RADIOACTIVE MATERIAL(S)” or “DANGER RADIOACTIVE MATERIAL(S)” in areas where nuclear gauges were used; (3) SL III violation of 10 CFR 30.50(b)(4) for failure to notify the NRC within 24 hours after the discovery of an unplanned fire on March 8, 2007, that damaged the integrity of a licensed device; and (4) SL III violation of License Condition 21 of Amendment 10 to NRC Materials License 33‑18224‑01 for failure to close and lock the nuclear gauge shutters after plant operations had stopped and prior to allowing welders to begin work, resulting in welders exposed to the direct radiation beam from these nuclear gauges.
Chicago Testing Laboratory, Inc. (EA-10-113)
On August 24, 2010, the NRC issued a Notice of Violation to Chicago Testing Laboratory, Inc., for a Severity Level III violation involving the possession and usage of byproduct material without authorization from a specific or general license. Specifically, on multiple occasions between July 6, 2006, and August 30, 2009, Chicago Testing Laboratory, Inc., an Agreement State licensee, possessed and used devices containing sealed sources in a non-Agreement State, and was not authorized in either a specific or general license.
Christiana Care Health Services (EA-10-141)
On August 24, 2010, the NRC issued a Notice of Violation to the Christiana Care Health Services (CCHS), for a Severity Level III violation involving the failure to develop and maintain written procedures to provide high confidence that each administration requiring a written directive was performed in accordance with the written directive as required by 10 CFR 35.41. Specifically, CCHS’s written procedures for high dose rate remote afterloader (HDR) treatments did not: (i) include a quality assurance process to test and evaluate proper functioning of all measurement tools used to determine treatment parameters; and, (ii) specify how personnel should respond when unknown and questionable treatment distances were encountered during HDR simulation measurements. As a result of these procedural inadequacies, a medical event occurred, in which the patient received a dose to unintended tissue and did not receive the prescribed dose to the intended tissue during an HDR treatment conducted between January 18 and January 22, 2010.
Department of Veteran Affairs (EA-10-081)
On August 23, 2010, the NRC issued a Notice of Violation (Notice) and Proposed Imposition of Civil Penalty in the amount of $39,000 to the Department of Veteran Affairs (VA) for two Severity Level III violations involving: (1) the failure to implement 10 CFR 35.41(a)(2) and 10 CFR 35.41(b)(2) requirements for verifying medical treatments, and (2) the failure to implement 10 CFR 35.3045(c) requirements to report a medical event. Additionally, the Notice issued a Severity Level III violation for three examples of both 10 CFR 35.41(a)(2) and 35.41(b)(2) violations involving five patients at the VA Boston Healthcare System during 2005, which is also beyond the statute of limitations time period such that a civil penalty was not assessed. Specifically, for the first set of violations assessed a civil penalty, several facilities are identified and involve multiple examples of the licensee’s failure to verify that the administration of permanent prostate brachytherapy implants was in accordance with the written directives: (i) the VA Sierra Nevada Health Care System in Reno, Nevada, between September 29, 2005 and October 12, 2008; (ii) the G.V. (Sonny) Montgomery VA Medical Center in Jackson, Mississippi, between May 2007 and February 2008; and, (iii) the VA Boston Healthcare System in Boston, Massachusetts on September 27, 2005. Further, the Notice identifies that the second violation assessed a civil penalty occurred on October 10, 2008, at the VA New York Harbor Healthcare System in Brooklyn, New York, where the licensee failed to make a timely medical event report regarding a permanent prostate brachytherapy implant when the data available at the time indicated otherwise, with the actual treatment dose less than 69 percent of the prescribed dose.
Bryan LGH Medical Center (EA-10-066)
On August 18, 2010, the NRC issued a Notice of Violation to Bryan LGH Medical Center dba Bryan LGH Heart Institute (Bryan Heart), 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, as of December 16, 2009, Bryan Heart, a holder of Nebraska State license, provided mobile nuclear medicine services at a temporary job site in the State of Missouri, a non-Agreement State, without filing a reciprocity submittal for calendar year 2009 with the NRC.
Southern Earth Sciences, Inc. (EA-10-110)
On July 19, 2010, the NRC issued a Notice of Violation to Southern Earth Sciences, Inc (SES), 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, between January 2008 and April 2009, SES, a holder of a Florida license, stored or used portable gauges in an area of exclusive federal jurisdiction without a specific license issued by the NRC, nor had SES filed a Form-241 with the NRC.
Laboratory Testing Services, LLC (EA-10-069)
On July 6, 2010, the NRC issued a Notice of Violation to Laboratory Testing Services, LLC (LTS) for a Severity Level III problem involving three violations. The first violation involved a failure to confine possession and use of byproduct material to the location authorized by the license, as required by 10 CFR 30.34(c). Specifically, the licensee possessed and used portable gauges at a location not authorized by the license. The second violation involved a failure to have an individual named on the license as a Radiation Safety Officer (RSO), as required by the license. Specially, the RSO named in the license left the company in June 2008, and the licensee failed to have an RSO approved by the NRC. The third violation involved a failure to obtain written consent from the NRC before transferring ownership of LTS to HAKS Material Testing Company (HAKS), as required by 10 CFR 30.34(b). Specifically, on January 14, 2010, LTS transferred ownership control of the license to HAKS without the Commission’s written consent.
Earth Engineers, Inc. (EA-10-062)
On June 28, 2010, the NRC issued a Notice of Violation to Earth Engineers, Inc., d.b.a. Heynen Engineers (EEI) for a Severity Level III problem involving two violations. The first violation involved a failure to comply with the conditions of the NRC Order Revoking License, issued on June 4, 2009. Specifically, the licensee did not pay fees within 30 days or transfer the licensed material to an authorized recipient within 60 days from the date of the Order. The second violation involved a failure to afford the NRC an opportunity to inspect the EEI facility, as required by 10 CFR 19.14(a). Specifically, on October 7, 2009, the licensee did not provide access to the nuclear portable gauge to inspect the condition of the gauge; and, between November 2, 2009 and January 27, 2010, the NRC made several attempts to contact the licensee, but the licensee did not provide access to the EEI facility.
Anthony & Edward Consultants (EA-10-068)
On June 25, 2010, the NRC issued a Notice of Violation to Anthony & Edwards Consultants (A&E) for a Severity Level III problem invovling three violations. The first violation invovled a failure to comply with the conditions of the NRC Order Revoking License, issued on July 28, 2009. Specifically, the licensee did not pay fees within 30 days or transfer the licensed material to an authorized recipient within 60 days from the date of the Order. The second violation involved a failure to afford the NRC an opportunity to inspect the A&E facility, as required by 10 CFR 19.14(a). Specifically between February 18, 2009 and September 17, 2009, the NRC made several attempts to contact the licensee to visit the facility and to schedule an inspection of licensed activities, but the licensee did not respond to these requests. And the third violation involved a failure to confine storage of licensed material to a location specified on the license, as required by 10 CFR 30.34(c). Specifically, from September 5, 2008 through at least September 30, 2009, the licensee stored the licensed material at a location not authorized by the license.
ArcelorMittal USA, Inc. (EA-10-044)
On June 2, 2010, the NRC issued a Notice of Violation to ArcelorMittal USA, Inc., for a Severity Level III violation involving the failure to ensure that only persons who have completed the licensee’s training program, the gauge manufacturer’s training course, or those persons specifically authorized by the Commission or an Agreement State remove gauges from service as required by license condition, Item 9. Specifically, on November 20, 2009, two individuals removed a gauge from service and neither individual had completed the licensee’s training program or the gauge manufacturer’s training course. In addition, on April 15, 2009, two other individuals removed a gauge from service, and one of those two individuals was not trained. None of the three individuals was authorized by the Commission or an Agreement State to remove gauges from service.
Department of Veterans Affairs (EA-10-023)
On June 2, 2010, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $14,000 to the Department of Veterans Affairs for two Severity Level III violations identified as a result of a medical event that occurred at the San Diego Healthcare System facility. The medical event resulted when iodine-131 was injected into the wrong port of the gastrostomy feeding tube (g-tube) resulting in an underdose to the patient’s thyroid and an unintended dose to the patient’s stomach. Specifically, the licensee’s written procedures did not include directions for administering byproduct material through a g-tube to ensure that the administered dose was in accordance with the written directive as required by 10 CFR 35.41(a)(2). Additionally, two nuclear medicine technologists had not been instructed on administering byproduct material through a g-tube prior to performing the administration in order to ensure that the administered dose was in accordance with the written directive. The second Severity Level III violation involved the licensee’s failure to notify the NRC Operations Center no later than the next calendar day after discovery of a medical event as required by 10 CFR 35.3045(c). Specifically, on September 23, 2009, the licensee had sufficient information, based on patient survey data and the image from the nuclear medicine department, to report the medical event and did not notify the NRC until September 26, 2009.
Yale-New Haven Hospital (EA-10-063)
On May 21, 2010, the NRC issued a Notice of Violation to Yale-New Haven Hospital (YNHH) for a Severity Level III violation involving the failure to develop and maintain written procedures to provide high confidence that each administration requiring a written directive was performed in accordance with the written directive as required by 10 CFR 35.41. Specifically, YNHH’s written procedures did not require a physical verification of the automatic position system coordinates against the electronic coordinates prior to initiation of gamma stereotactic radiosurgery (GSR) treatment and did not specify how hospital personnel should respond to unexpected GSR treatment console errors. These procedural inadequacies resulted in a medical event, when YNHH personnel did not verify that the automatic position system coordinates were in accordance with the written directive, during the treatment of a patient undergoing GSR on August 5, 2009.
SSM St. Clare Health Center (EA-10-025)
On April 19, 2010, the NRC issued a Notice of Violation to SSM St. Clare Health Center for a Severity Level III violation involving the failure to implement written procedures to provide high confidence that each administration was in accordance with the written directive as required by Title 10 of the Code of Federal Regulations (CFR), Section 35.41. Specifically, between November 19, 2008, and September 23, 2009, the licensee failed to follow its procedures which required the preparation of final computerized treatment plans for two patients whose prostates had been implanted with radioactive seeds. The seeds were implanted on October 22, 2008, and their computed tomography (CT) studies were performed on November 19, 2008. However, the licensee still had not prepared the final treatment plans for these patients at the time of the inspection.
On April 16, 2010, the NRC issued a Confirmatory Order (effective immediately) to CAN USA, Inc. to formalize commitments made as a result of an ADR mediation session. The commitments were made by CAN USA, Inc. as part of a settlement agreement between CAN USA, Inc. and the NRC regarding apparent willful violations of NRC requirements by a radiographer and radiographer’s assistant. The agreement resolves the apparent violations involving the CAN USA failures, which were identified during NRC inspection and investigation by the NRC Office of Investigations, and include the following areas: (1) failure to have a radiographer and at least one other individual qualified pursuant to 34.43(c); (2) failure to have a radiographer supervise and maintain direct observation of the assistant during use of a radiographic device; and (3) failure to control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and not in storage. CAN USA, Inc. agreed to a number of corrective actions, including the following: new and specific changes to operating procedures; activities related to training on new and/or revised operating procedures; interim training until the procedures are completed; unannounced audits; additional oversight of radiography crews; and specific written agreements with clients that address radiographic operations. In consideration of these commitments, the NRC agreed to limit the civil penalty amount to $7,000 and not to pursue any further enforcement action in connection with the inspection.
U.S. Department of Veterans Affairs (EA-09-038)
On March 17, 2010, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $227,500 to the U.S. Department of Veterans Affairs for violations related to activities at the Philadelphia Veterans Affairs Medical Center (PVAMC). The following areas of violation were identified: (1) Severity Level II violations of 10 CFR 35.41(a)(2) for failure to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive, resulting in a total of 74 prostate brachytherapy treatments where the administered radiation dose was not in accordance with the written directive; (2) a Severity Level II violation of 10 CFR 35.41(b)(2) for failure to have procedures that addressed verifying that the administration was in accordance with the applicable treatment plan and written directive , resulting the licensee administering at least 16 prostate brachytherapy treatments without performing post-treatment verifications until a prolonged period of time had passed; (3) a separate Severity Level III violation of 10 CFR 35.41(b)(2) related to the the licensee’s failure to identify that the treatment plan for a brachytherapy treatment differed from the written directive, resulting in the wrong seeds being ordered and administered; (4) a Severity Level III problem involving violations of 10 CFR 35.27(a)(1) and 19.12(a)(4) for failing to instruct individuals about procedures, 10 CFR Part 35 and licensing requirements, and prompt reporting of conditions that resulted in to two medical physicists not being instructed in the requirements for identifying and reporting medical events (10 CFR 35.2 and 35.3045) and an authorized user physician not being instructed of his responsibility to report to the licensee any condition that may lead to or cause a violation; (5) a Severity Level III violation of 10 CFR 35.3045(c) for failure to report to the NRC Operations Center no later than the next calendar day when they had information that medical events occurred; and (6) two Severity Level IV violations.
City of South Bend, Indiana (EA-10-014)
On March 10, 2010, a Notice of Violation was issued to the City of South Bend for a Severity Level III violation involving Condition 11.B of the facility's license which authorized a specifically named individual to fulfill the responsibilities of the Radiation Protection Officer. Specifically, as of January 19, 2010, the named individual was no longer employed by the company. The licensee failed to appoint a new Radiation Protection Officer and had not amended the license.
Troxler Electronic Laboratories, Inc. (EA-09-082)
On March 9, 2010, the NRC issued a Notice of Violation for a Severity Level III violation involving the failure to implement 10 CFR 110.20(a)(2) and 10 CFR 110.41(a)(9). Specifically, on November 21, 2008, Troxler Electronic Laboratories, Inc., failed to apply for a specific license and exported byproduct material listed in Appendix L (a moisture density gauge containing Am-241) to an embargoed country listed in 10 CFR 110.28 (Iraq). Further, this failure to apply for a specific export license prevented an Executive Branch review of the export activity as required by 10 CFR 110.41(a)(9).
National Institute of Standards and Technology (EA-09-142)
On March 1, 2010, the NRC issued an Immediately Effective Confirmatory Order to the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST or licensee) to confirm commitments made as a result of an Alternate Dispute Resolution mediation session held on January 5, 2010. This enforcement action is based on ten apparent violations of NRC requirements at NIST’s facility in Boulder, Colorado, which were identified during NRC inspection and investigation activities conducted in response to a June 9, 2008 plutonium spill. The apparent violations involved the licensee’s failure to conduct the radiation safety program at NIST-Boulder in accordance with NRC requirements and the conditions of the NIST-Boulder license. The licensee agreed to take the following actions: (1) complete an independent assessment of the radiation safety program at NIST-Boulder; (2) submit copies of the required annual radiation safety audit to the NRC; (3) develop and implement a procedure for training new employees on radiation safety policies and procedures; (4) upgrade initial and refresher training for employees who work with radioactive materials, including a review of lessons learned from the plutonium spill and the associated apparent violations; (5) submit a license amendment request for deletion of the radionuclides on the NIST-Boulder license that NIST no longer plans to use; (6) develop a formal radiation hazards analysis process; (7) revise the NIST Ionizing Radiation Safety Committee charter to require additional review of NRC submittals; (8) revise the NIST radiation safety program policy to indicate that all individuals interacting with the NRC are required to provide complete and accurate information; (9) develop a clearly defined process for acquiring radioactive materials; and (10) pay a civil penalty of $10,000. In consideration of these commitments, and other actions already completed by NIST, the NRC agreed not to pursue any additional enforcement actions for the apparent violations or count this matter as previous enforcement for the purposes of assessing potential future enforcement actions in accordance with Section VI.C of the Enforcement Policy.
Gamma Knife Center of the Pacific (EA-09-289)
On February 23, 2010, the NRC issued a Notice of Violation for a SLIII violation to Gamma Knife Center of the Pacific for a failure to implement 10 CFR 35.41(b). Specifically, as of July 2, 2009, the licensee failed to develop, implement, and maintain written procedures to provide high confidence that each medical administration is in accordance with the written directive in that the procedures did not require explicit verification that the administration was in accordance with the treatment plan and written directive. Consequently, the treatment plan and written directive were not followed to ensure that the collimator was used in the treatment of a patient.
Kanawha Scales & Systems, Inc. (EA-09-312)
On February 18, 2010, the NRC issued a Notice of Violation to Kanawha Scales & Systems, Inc., a licensee of the State of Ohio, for a Severity Level III violation involving 10 CFR 150.20. Specifically, on November 2, 2009, Kanawha Scales & Systems, Inc., used sealed sources in 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.
Nanticoke Memorial Hospital (EA-09-335)
On February 2, 2010, the NRC issued a Notice of Violation to Nanticoke Memorial Hospital 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, Nanticoke Memorial Hospital became aware that a medical event had occurred on June 26, 2009, but the NRC was not notified until July 15, 2009.
Great Falls Clinic (EA-09-290)
On January 21, 2010, the NRC issued a Notice of Violation to Great Falls Clinic for violations associated with a Severity Level III problem involving the failure to: (1) secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas, in violation of 10 CFR 20.1801 and (2) secure the unit, console, console keys and the treatment room when not in use or unattended, in violation of 10 CFR 35.610 (a)(1). Specifically, the licensee stored a high dose-rate remote afterloader unit in a designated controlled area and did not secure the radioactive material from unauthorized removal or access. The console and unit were found in the unattended and not secured, designated controlled area. The console was found with its key inserted.
CJW Medical Center - Johnston-Willis Campus (EA-09-040)
On January 21, 2010, the NRC issued a Notice of Violation to CJW Medical Center - Johnston-Willis Campus for a violation of 10 CFR 35.41(a)(2) associated with 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 written directives. Specifically, as of December 16, 2008, the licensee's procedures did not require verification of the treatment site nor resolution of any inconsistencies in the written directive prior to administration of the dose. This resulted in a patient receiving treatment to the left trigeminal nerve instead of to the originally-intended site (right trigeminal nerve).
Beta Gamma Nuclear Radiology, Inc. (EA-09-147)
On January 21, 2010, the NRC issued a Notice of Violation (NOV) and Immediately Effective Confirmatory Order to Beta Gamma Nuclear Radiology, Inc., (BGNR) to confirm commitments made as a result of an Alternative Dispute Resolution (ADR) mediation session held on October 27, 2009. This enforcement action is based on a violation of 10 CFR 30.9 which requires, in part, that information provided to the Commission by a licensee, or information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects. Contrary to this requirement, in a May 5, 2008 response contesting a Severity Level IV Notice of Violation, BGNR maintained, and provided to the NRC, information that was not complete and accurate in all material respects. Specifically, the BGNR response stated that three written directives, administered on September 14, 2005, and February 19 and 26, 2008, were written prior to the administrations, when in fact, the written directives were signed and dated after the administrations. The written directives were required to be maintained by 10 CFR 35.40(a), and were therefore, material to the NRC. BGNR agreed to: (1) perform quarterly comprehensive radiation safety audits and (2) authorize a new RSO for a two year period. In recognition of these commitments, the NRC agreed to issue to BGNR a civil penalty in the amount of $5,000 and also issue an NOV containing a SL III violation of 10 CFR 30.9.
On January 6, 2010, the NRC issued a Notice of Violation to Allegiance Health for a Severity Level III violation involving the failure to develop written procedures to provide high confidence that the administration was in accordance with the written directive as required by Title 10 of the Code of Federal Regulations (CFR), Section 35.41. Specifically, on April 16, 2009, the licensee’s procedures did not contain any steps to ensure that no changes had occurred in the patients’ prostate volume between the time the treatment plan was prepared and the administration of the treatment and no other method was provided to ensure that the administration was in accordance with the written directive.
