2020 Materials Actions
This page includes links to files in non-HTML format. See Plugins, Viewers, and Other Tools for more information.
TTL Associates (EA-20-110)
On December 3, 2020, the NRC issued two Severity Level III Notices of Violation to TTL Associates, Inc. (TTL) for a violation of 10 CFR 20.1802 and Condition 14 of its license. Specifically, on July 7, 2020, the TTL failed to control and maintain constant surveillance of a portable moisture density gauge located in an unrestricted area. Also, TTL detached a sealed source containing licensed material from the source rod without being specifically authorized to do so and in contrast to the requirement specified on its license.
The Queen’s Medical Center (EA-20-051)
On October 27, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty (CP) in the amount of $ 7,500 to The Queen’s Medical Center (Queen’s) for a Severity Level III problem associated with three related violations. The violations involve Queen’s failure to monitor exposure to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of 10 CFR Part 20. Specifically, nine interventional radiologist physicians, whose occupational exposure exceeded 10 percent of the limits in 10 CFR 20.1201(a), were not monitored over the course of several years (from January 2011 to May 28, 2019). Additionally, the licensee failed to provide adequate instructions regarding the proper use of dosimeters to the nine radiologist physicians who were likely to receive in a year an occupational dose in excess of 100 mrem, in violation of 10 CFR 19.12(a)(3). Finally, in violation of 10 CFR 20.1101(a), Queen’s failed to implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with 10 CFR Part 20. Specifically, the licensee’s radiation safety committee failed to adequately review (1) the quarterly summary report of occupational exposure records for compliance with dosimeter usage and (2) the summary report of the radiation safety program regarding safety and compliance, as well as failed to recommend action to correct deficiencies. Queen’s policy and the Radiation Safety Plan failed to address actions to be taken when dosimeters were returned unused or recorded unexpectedly low exposures.
International Isotopes, Inc. (EA-20-073)
On October 20, 2020, the NRC issued a Notice of Violation to International Isotopes, Inc. (INIS) for a Severity Level II problem involving two violations. Specifically, (1) INIS failed to have appropriate administrative procedures that assured the completion of safety evaluations as required by 10 CFR 31.13(c)(3); and (2) the INIS radiation safety committee inappropriately approved procedures that changed the conditions of the NRC license and that decreased the effectiveness of the radiation safety program. The NRC considers these violations to be significant because the inadequate procedures directly contributed to a significant contamination event at the University of Washington's Harborview Medical Center on May 2, 2019.
Sanford Medical Center (EA-20-050)
On October 16, 2020, the NRC issued a Notice of Violation (Notice) to Sanford Medical Center (Licensee) for a Severity Level III problem associated with three related violations. The violations involved the licensee’s failure to: (a) monitor occupational exposure of workers from licensed and unlicensed sources of radiation as required by Title 10 of the Code of Federal Regulations (10 CFR) 20.1502(a)(1); (b) develop and implement certain elements of its radiation protection program in accordance with 10 CFR 20.1101(a); and (c) provide instructions to individuals in accordance with 10 CFR 19.12(a)(3). Specifically, during specific timeframes identified in the Notice, the licensee did not monitor the occupational exposure to radiation from unlicensed radiation sources and the use of individual monitoring devices by an authorized user, did not provide instructions for further investigation or other actions when there was a discrepancy in dosimetry readings, and failed to provide adequate instructions regarding the proper use of personnel dosimeters to an authorized user who was likely to receive an occupational dose in excess of the required annual limit. Additionally, a Severity Level IV violation was issued to the licensee for failing to submit a written report within 30 days after learning of a dose in excess of the occupational dose limits for adults in 10 CFR 20.1201 as required by 10 CFR 20.2203(a)(2)(i).
St. Joseph Regional Medical Center, Inc. (EA-19-132)
On October 7, 2020, the NRC issued an NOV and proposed imposition of a CP in the amount of $7,500 to St. Joseph Regional Medical Center, Inc. (licensee) for a SLIII Problem involving three violations occurring between June 1, 2016 and October 21, 2019. These violations involved the licensee’s failure (1) to prepare written directives that were dated and signed by an authorized user before the administration of iodine-131 sodium iodide greater than 30 microcuries and therapeutic doses of palladium-103 (10 CFR 35.40(a)), (2) to ensure that written directives for the administration of a therapeutic dosage of unsealed radium-223 contained the dosage and route of administration (10 CFR 35.40(b)(2)), and (3) to develop, implement, and maintain written procedures to provide high confidence that each administration requiring a written directive is in accordance with the written directive (10 CFR 35.41(a)(2)).
International Isotopes, Inc. (EA-20-095)
On September 17, 2020, the NRC issued a Notice of Violation to International Isotopes, Inc. (INIS) for a Severity Level III violation. The violation involved multiple exports of byproduct material by INIS to an embargoed destination without a specific license. Specifically, on May 24, May 29, October 2, and December 4, 2019, INIS exported byproduct material in four separate shipments to Iraq, an embargoed destination, without the required NRC specific license in accordance with 10 CFR Part 110.5, "Licensing Requirements".
St. Luke's Regional Medical Center (EA-20-065)
On September 15, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $7,500 to St. Luke’s Regional Medical Center (Licensee) for a Severity Level III problem associated with three related violations. The violations involved the licensee’s failure to: (a) monitor occupational exposure of workers from licensed and unlicensed sources of radiation as required by Title 10 of the Code of Federal Regulations (10 CFR) 20.1502(a)(1); (b) develop and implement certain elements of its radiation protection program in accordance with 10 CFR 20.1101(a); and (c) provide instructions to individuals in accordance with 10 CFR 19.12(a)(3). Specifically, from January 1, 2012, to February 24, 2020, the licensee did not properly monitor interventional radiology (IR) physicians whose occupational exposure exceeded the NRC’s annual radiation exposure limit over the course of 8 years and did not develop and implement a radiation protection program commensurate with the scope and extent of its licensed activities. Additionally, the licensee did not provide instructions regarding radiation safety involving the proper use and storage of dosimeters to four IR physicians who were likely to receive an occupational dose in excess of the required annual limit.
Avera McKennan (EA-20-003)
On August 12, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $7500, to Avera McKennan (Licensee) for a Severity Level III problem associated with three related violations. The violations were significant because they were associated with programmatic failures in the licensee's dosimetry program and because individuals had a substantial potential to exceed NRC occupational exposure limits. The apparent violations involved the licensee's failure to: adequately monitor occupational exposure per 10 CFR 20.1502(a)(1); follow its radiation protection program per 10 CFR 20.1101(a); and report an occupational dose in excess of the dose limits per 10 CFR 20.2203(a)(2)(i).
Centro Comprensivo de Cancer de la UPR (EA-20-010)
On June 30, 2020, the NRC issued a Notice of Violation to Centro Comprensivo de Cancer de la UPR (Licensee), for a Severity Level III problem associated with two related violations. The first violation involved licensee's failure to maintain or adequately control a high dose rate remote afterloader (HDR) unit, the HDR console, the console keys, and the HDR treatment room as required by Title 10 of the Code of Federal Regulations (10 CFR) 35.610(a)(1) and the second violation involved the resultant failure by the licensee to secure from unauthorized removal or access licensed material as required by 10 CFR 20.1802. Specifically, on November 21, 2019, the licensee's medical physicist left the treatment room area and inadvertently left the HDR console keys in the console and the key securing the HDR unit, as well as the key and keycard used to access the outer door of the HDR unit room, unsecured on the desk and during this period the licensed material was not secured from unauthorized removal or access.
Hot Asphalt Paving, Inc. (EA-19-096)
On June 24, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $7,500 to Hot Asphalt Paving, Inc. (Licensee) for a Severity Level III violation. The violation involved the licensee's failure to complete decommissioning of its site within 24 months of initiation of decommissioning and failed to receive an approval by NRC for an alternate schedule for decommissioning as required by Title 10 of the Code of Federal Regulations (10 CFR) 30.36(h) and 10 CFR 30.36(j). Specifically, on September 3, 2014, Hot Asphalt Paving, Inc. notified the NRC that the company was no longer conducting licensed activities and as of June 24, 2020, which is more than 24 months from the notified date, Hot Asphalt Paving, Inc. did not transfer its nuclear gauges in order to certify the disposition of its licensed material and did not complete decommissioning activities. In addition, the licensee did not receive an approval by NRC for an alternate schedule for decommissioning as required by 10 CFR 30.36.
Bayou Inspection Services, Inc. (EA-20-046)
On June 22, 2020, the NRC issued a Notice of Violation to Bayou Inspection Services, Inc. (Licensee) for a Severity Level III violation. The violation involved the licensee's 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 February 20, 2020, Bayou Inspection Services, Inc, a licensee of the State of Louisiana, engaged in licensed activities in the Gulf of Mexico, without filing the required documentation with the NRC.
Christian Wheeler Engineering (EA-20-047)
On June 18, 2020, the NRC issued a Notice of Violation to Christian Wheeler Engineering (Licensee) for a Severity Level III violation. The violation involved the licensee's 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, from January 7 through February 20, 2020, Christian Wheeler Engineering, a licensee of the State of California, performed licensed activities at Camp Pendleton, Oceanside, California and from February 19 through 20, 2020, at Marine Corps Air Station Miramar/Naval Air Station, San Diego, California, without filing the required documentation with the NRC.
Alt and Witzig Engineering, Inc. (EA-20-014)
On May 13, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $8,500 to Alt and Witzig Engineering, Inc. (Licensee) for a Severity Level (SL) III violation associated with the theft of a portable gauge due to the licensee's failure to secure the gauge as required, and for a second SL III violation for the licensee’s failure to immediately notify the NRC of the stolen gauge. Specifically, on October 3, 2019, the licensee failed to secure a portable gauge with two independent physical barriers while not under its control and constant surveillance, as required by Title 10 of the Code of Federal Regulations (10 CFR) 30.34(i) and 10 CFR 20.1801, and the gauge was stolen. In addition, the licensee did not immediately notify the NRC of the stolen gauge in accordance with 10 CFR 20.2201.
Thrasher Engineering Inc. (EA-19-136)
On April 27, 2020, the NRC issued a Notice of Violation and Proposed Imposition of a civil penalty in the amount of $7,500 to Thrasher Engineering Inc. (licensee), for a Severity Level III violation. The violation involved the licensee’s repeat failure to use two independent physical controls that form tangible barriers to secure a portable gauge from unauthorized removal as required by 10 CFR 30.34(i). Specifically, on October 29, 2019, the licensee’s gauge user left a portable gauge in the bed of a pickup truck, with only a single locked case to secure the portable gauge from unauthorized removal, when he was inside the construction site trailer and did not have control and constant surveillance of the portable gauge.
Lantheus Medical Imaging (EA-19-068)
On April 23, 2020, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $7,500 to Lantheus Medical Imaging (Licensee) for a Severity Level III problem associated with two related violations for deliberate misconduct by a former senior technical support specialist and a SL III violation for the licensee's failure to comply with a condition of its NRC license. The first two violations involved the licensee's failure to: (1) monitor the occupational radiation exposure of a former employee as required by Title 10 of the Code of Federal Regulations (10 CFR) Section 20.1502, and (2) provide related information to the Nuclear Regulatory Commission (NRC) that was complete and accurate in all material respects, as required by 10 CFR 30.9(a). The third violation involved the licensee’s failure to comply with Condition 12 of its NRC license, which required that licensed material shall be used by, or under the supervision of, an individual specifically named in the license. Specifically, between January 2014 and December 2017, the licensee did not monitor occupational exposure to radiation from licensed sources and because a former employee did not always wear required dosimetry, his annual exposure to radiation could have excessed the regulatory limit. Additionally, on August 15, 2018, the licensee terminated the employment of the supervising individual listed in Condition 12 of its NRC license, and the license amendment request was not submitted until September 21, 2018.
Schultz Surveying & Engineering, Inc. (EA-19-108)
On March 11, 2020, the NRC issued a Notice of Violation and Exercise of Discretion to Schultz Surveying & Engineering, Inc. (Licensee) for a Severity Level III problem associated with three related violations. The violations involved the licensee’s failure to: (a) have the named individual on its license perform the duties and responsibilities of the Radiation Safety Officer (RSO) as required by License Condition No. 11 of NRC License No. 24-32159-01; (b) transfer the byproduct material to an authorized person as required by Title 10 Code of Federal Regulations (10 CFR) Part 30.41(a); and (c) provide a written response to an April 30, 2018, Order revoking the license based on non-payment of license fees. Specifically, the RSO named on the license left the employment and there was no qualified RSO since December 2016, and on January 31, 2017, the licensee transferred byproduct material to a person not authorized to receive such byproduct material under terms of a specific license or a general license or their equivalents issued by the Atomic Energy Commission, the NRC, or an Agreement State. As part of its corrective actions, the licensee submitted a request to terminate its NRC license. In accordance with Section 3.6 of the Enforcement Policy, the NRC exercised discretion to not propose a civil penalty and terminated the license on February 20, 2020.
Avera St. Luke’s Hospital (EA-19-126)
On March 11, 2020, the NRC issued a Notice of Violation to Avera St. Luke’s Hospital (Licensee) for a Severity Level III problem associated with three related violations. The violations involved the licensee’s failure to: (a) monitor occupational exposure of workers from licensed and unlicensed sources of radiation as required by Title 10 of the Code of Federal Regulations (10 CFR) 20.1502(a)(1); (b) develop and implement certain elements of its radiation protection program in accordance with 10 CFR 20.1101(a); and (c) submit a written report to the NRC within 30 days of discovery of a reportable event in accordance with 10 CFR 20.2203. Specifically, from February 2018 through July 30, 2019, the licensee did not properly monitor an authorized user’s radiation exposure that resulted in the authorized user having a significant potential to exceed the NRC’s annual radiation exposure limit and did not develop and implement a radiation protection program commensurate with the scope and extent of its licensed activities. Additionally, on October 3, 2018, the licensee was notified by a dosimetry vendor of an exposure potentially exceeding the NRC’s annual exposure limits for an authorized user working under its NRC license, and the licensee did not investigate or notify the NRC until July 30, 2019.
Sanders Medical Products (EA-19-141)
On March 3, 2020, the NRC issued a Notice of Violation to Sanders Medical Products (SMP) for two Severity Level III violations. The first violation involved SMP not filing an application for a specific license to the Deputy Director of the Office of International Programs, to export a Ge-68 1,581 µCi source, using an appropriate method listed in 10 CFR Part 110.4. Specifically, on June 3, 2019, SMP attempted to export a Ge-68 1,581 µCi source to Tehran, Iran, without filing an application for a specific license, when such activity would have been required to be authorized by the NRC. Therefore, no export application was filed, and the shipment was not authorized by a specific license issued under 10 CFR Part 110. The second violation involved SMP exporting a Ge-68 1,581 µCi source without being authorized by a specific license issued under 10 CFR Part 110. Specifically, on November 26, 2018, SMP exported to Alchemy Scientific Bureau in Baghdad, Iraq, a Ge-68 1,581 µCi source without a specific license, when such activity would have been required to be authorized by the NRC. Therefore, no export license was issued, and the shipment was not authorized by a specific license issued under 10 CFR Part 110.
Municipality of Anchorage (EA-19-127)
On February 13, 2020, the NRC issued a Notice of Violation to Municipality of Anchorage (Licensee), for a Severity Level III violation related to an NRC licensing requirement. The violation involved the licensee’s failure to have the named individual on its license perform the duties and responsibilities of the Radiation Safety Officer (RSO) for the period from September 30, 2017, through January 6, 2020, as required by License Condition 12 of NRC Materials License 50-15852-02. Specifically, the RSO listed on the license retired on September 30, 2017, and the license was not amended to name a new RSO until January 7, 2020.
Bittner Engineering, Inc. (EA-19-079)
On February 12, 2020, the NRC issued a Notice of Violation to Bittner Engineering, Inc. (Licensee) for a Severity Level III problem associated with four related violations. The violations involved the licensee’s failure to: (1) have the named individual on its license perform the duties and responsibilities of the Radiation Safety Officer (RSO) as required by License Condition 12 of NRC License 21-26010-01; (2) perform leak tests of sealed sources in accordance with License Condition 13 of NRC License 21-26010-01; (3) perform a review and implementation of radiation safety program as required by Title 10 Code of Federal Regulations (10 CFR) Part 20.1101(c); and (4) provide hazmat employees with the hazmat refresher training as required by 10 CFR 71.5(a). Specifically, the RSO named on the license retired in 2014 and the license was not amended to name a new RSO until May 23, 2019. Additionally, between December 2014 and May 23, 2019, the licensee did not perform the annual leak tests on the portable gauges, did not perform the required review of the radiation safety program, and did not provide the required recurrent training for its hazmat employees.
