EA-97-189 - DMS Imaging, Inc.
February 24, 1999
Mr. Dennis Clemenson, President
and Radiation Safety Officer
DMS Imaging, Inc.
P.O. Box 1010
Bemidji, MN 56601
|SUBJECT: ||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,500 (NRC Inspection Report 030-10809/96001(DMNS), NRC Office of Inspector General (OIG) Investigation Report 97-79G, and NRC Office of Investigations (OI) Reports 3-96-045 & 3-96-45S) |
Dear Mr. Clemenson:
This refers to the August 23, 1996, NRC inspection and the OI and OIG investigations conducted between November 13, 1996, and November 4, 1998. The purpose of the inspection was to review DMS Imaging, Inc. (DMS), licensed activities. The investigations were conducted to follow up on statements made by your staff during the inspection and the May 13, 1997, predecisional enforcement conference (conference) held in the NRC Region III office. The inspection and investigations findings were sent to you by letters dated April 29, 1997, and November 20, 1998. Because of the new information DMS was offered the opportunity to attend a second predecisional enforcement conference, which you declined.
Based on the information developed during the inspection, the OI and OIG investigations, the information provided during the 1997 conference, and the information provided in your letter dated December 2, 1998, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty, and the circumstances surrounding them are described in detail in the subject inspection report.
During the May 13, 1997, conference, violations involving the failure of staff to wear lab coats and proper dosimetry when handling radioactive materials were discussed. DMS provided its corrective actions during the conference and those actions appeared appropriate. A subsequent inspection was conducted on December 15 and 16, 1997, and confirmed the adequacy of the corrective actions implemented. However, based on the findings of the OIG report, the NRC staff concludes that the violation involving failure to wear dosimetry occurred because a DMS supervisor deliberately allowed the technologist to perform routine nuclear medicine duties, knowing that the technologist had not yet obtained the required dosimetry.
A second violation identified during the investigations involves the failure of DMS employees, on October 1, 1996, to provide complete and accurate information to an NRC investigator about performing licensed activities without wearing dosimetry. This violation is of significant concern to the NRC. DMS employees claimed that a newly-hired technologist did not handle radioactive material prior to receiving dosimetry when, in fact, the technologist had eluted a generator, prepared doses and injected patients prior to receiving dosimetry. Based on the findings of the OIG report, the NRC staff concludes that the same DMS supervisor deliberately instructed the DMS employees to provide the inaccurate information to the NRC investigator.
The explanation given by the DMS supervisor is that he was concerned about the consistency of the answers that the DMS employees would provide to the NRC investigator, i.e., that they should be the same as those given to the NRC inspector by the employees during the August 23, 1996, inspection. However, the standard is not consistency, but rather accuracy and truthfulness. The importance of promptly identifying and correcting inaccurate or incomplete information provided to the NRC is emphasized in Section IX of the NRC's "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, Rev 1. Moreover, the DMS employees were, in fact, truthful with the NRC inspector during the August 23, 1996, inspection. Thus, a concern for consistency would dictate that they be truthful with the NRC investigator as well.
It is essential that the NRC be able to maintain the highest trust that individuals supervising or working with radioactive materials will comply with regulatory requirements. The NRC's regulatory programs are based on licensees and their employees acting with integrity and conducting their programs in an open and honest manner, and DMS, as an entity licensed to possess and use radioactive material, is responsible for the acts of its employees. Therefore, because of the willful nature of these violations, they have been categorized as a Severity Level III problem in accordance with the Enforcement Policy.
The NRC is corresponding directly with the DMS supervisor and the nuclear medicine technologists concerning these issues. You will receive a copies of that correspondence under separate cover.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. Because the violations involve willfulness, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. NRC staff identified the violations; consequently, credit for identification is not warranted. Credit for corrective action is warranted based on the following actions taken by DMS: (1) adding a written notice to the new hire orientation which informs nuclear medicine personnel that it is imperative that they abide by all DMS policies and procedures, and that they ensure that all NRC policies are carried out to maintain strict compliance with NRC licensing; (2) establishing that failure to abide by all policies and procedures will result in immediate employment termination; and (3) requiring all new hires and existing nuclear medicine technologists to acknowledge by signature that they have received and understand the notice. The initial issue of providing dosimetry and lab coats was discussed during the May 13, 1997, conference. DMS instituted a policy that, prior to beginning the orientation, a new hire technologist will be issued lab coats and other protective clothing and proper personnel monitoring devices.
Therefore, to emphasize the importance of providing accurate and complete information to the NRC, procedural compliance, and prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,500 for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. Your response should include your basis for concluding that the DMS supervisor will not, in the future, commit willful violations of NRC requirements and that he is committed to assuring that all NRC requirements are followed and that information provided to the NRC is complete and accurate in all material respects. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
All final NRC documents, including the final OIG investigation report, are official agency records and may be made available to the public under the Freedom of Information Act (FOIA), subject to redaction of information in accordance with the FOIA.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room.
| ||Sincerely, |
|Original Signed By |
|James E. Dyer |
Docket No. 030-10809
License No. 22-16328-01
Notice of Violation and Proposed Imposition of Civil Penalty
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|DMS Imaging, Inc. |
| ||Docket No. 030-10809 |
License No. 22-16328-01
During an NRC inspection and investigations conducted between August 23, 1996, and November 4, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:
|I. || |
Condition 16 of License No. 22-16328-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated June 27, 1991, which includes implementation of Appendix I to Regulatory Guide 10.8, Revision 2., Item 7 of Appendix I, "Model Rules for Safe Use of Radiopharmaceuticals," requires individuals to wear personnel monitoring devices at all times while in areas where radioactive materials are used or stored. Item 8 of Appendix I requires individuals to wear a finger exposure monitor during the elution of generators; during the preparation, assay and injection of radiopharmaceuticals; and when holding patients during procedures.
Contrary to the above, on August 21 and 23, 1996, a newly-hired technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices.
|II. || |
10 CFR 30.9(a) 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 the above, on October 1, 1996, information provided by licensee employees to an NRC investigator was inaccurate. Specifically, two of the licensee's nuclear medicine technologists, in response to questions regarding the use of licensed material, told the NRC investigator that one of them, a newly-hired technologist, did not elute generators or inject patients during the period of August 19 through 23, 1996. These statements were inaccurate in that on August 21 and 23, 1996, the newly-hired technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices. This information is material because it could have influenced the NRC as to whether a violation existed, and if so, the scope of that violation.
These violations represent a Severity Level III problem (Supplements VI and VII).
Civil Penalty – $2,500
Pursuant to the provisions of 10 CFR 2.201, DMS Imaging, Inc. (Licensee), is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, 801 Warrenville Road, Lisle, IL 60532-4351.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 24th day of February 1999
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