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EA-00-288 - Biomedical Scanning Services, Inc.

February 21, 2001

EA-00-288

James Halstead
President
Biomedical Scanning Services, Inc.
9445 Chavez Drive
St. Louis, MO 63126

SUBJECT:   NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $8800 (INVESTIGATION REPORT NO. 3-2000-014)

Dear Mr. Halstead:

This refers to the Office of Investigations (OI) report number 3-2000-014, completed on December 15, 2000, to determine whether byproduct material was deliberately ordered to be delivered to an unauthorized location. On March 3, 2000, a review of licensed activities was conducted to evaluate whether receipt of byproduct material was in accordance with your license and NRC requirements. This review identified an apparent deliberate violation involving the delivery of byproduct material directly to a hospital. Based on this review, the OI investigation was performed. The OI investigation identified additional apparent violations. Our January 12, 2001 letter, discussed the apparent violations, and our decision to hold a predecisional enforcement conference with you, and provided you a summary of the OI investigation. On January 25, 2001, a predecisional enforcement conference was conducted in the Region III office, Lisle, Illinois, with you to discuss the apparent violations, their significance, their root causes, and your corrective actions.

On December 23, 1997, Biomedical received a license amendment, which required Biomedical to comply with statements in its letter dated September 29, 1997, and an undated letter received on December 17, 1997. The amendment authorized the delivery of byproduct material to Biomedical's mobile nuclear van at 777 New Ballas Road, St. Louis, Missouri, in the presence of an authorized user. On December 23, 1997, Biomedical began receiving byproduct material at its mobile nuclear van; however, an authorized individual was not always present during the delivery of byproduct materials. This violation was identified during the OI investigation.

In October 1998, Biomedical began ordering byproduct material to be delivered directly to St. Genevieve Memorial Hospital, a client's address of use, in violation of NRC requirements. During a January 26, 2000 inspection, the President/Radiation Safety Officer (RSO), when questioned about receipt of byproduct material, failed to inform the inspector that an authorized individual was not always present during the delivery of material to the mobile van and that material was being delivered directly to a hospital. Further, the President/RSO questioned the inspector about how Biomedical could arrange to receive unit doses at a client hospital and was advised by the inspector that a license amendment would be required. Based on these omissions, no violations of NRC requirements were identified during this inspection. The March 3, 2000 review, identified a violation involving the ordering of byproduct material for direct delivery to a client's address of use. The review also identified that the President/RSO may have deliberately failed to follow delivery requirements. During the March 3, 2000 review, the President/RSO stated that he was not advised by the NRC until the January 26, 2000 inspection, that having byproduct material delivered directly to a hospital was a violation. However, the President/RSO was informed during a June 7, 1999, telephone conversation with an NRC license reviewer, that the direct delivery of byproduct material to a client's address of use was not allowed by the regulations. In addition, the President/RSO stated that receipt of byproduct material at the hospital had been discontinued on January 26, 2000, when in fact, receipt of material was not discontinued until February 10, 2000. The OI investigation concluded that the President/RSO deliberately provided inaccurate and incomplete information to NRC staff in both January and March 2000, when questioned about the delivery and receipt of byproduct materials.

Based on the information developed during the inspection and review, the investigation, and the additional information that you provided during the predecisional enforcement conference, the NRC has determined that deliberate violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described above. The violations involved: (1) the failure to have an authorized individual always present during the delivery of byproduct material to Biomedical's mobile van; (2) ordering byproduct material to be delivered directly to a client's address of use; and (3) providing inaccurate or incomplete information to NRC inspectors when questioned about the delivery and receipt of byproduct materials.

In accordance with Supplement VII to the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, May 1, 2000, providing inaccurate and incomplete information to the NRC by a licensee official (President/RSO) such that if the information had been complete and accurate would have resulted in the NRC taking a different regulatory position(1) is categorized at Severity Level II. The violations involving the delivery of byproduct materials have low safety significance, since the byproduct materials were placed into secured areas. However, it is essential that the NRC be able to maintain the highest confidence that licensees and their employees will abide by requirements designed to maintain security and control over byproduct material and to protect the health and safety of the public. Therefore, based on the deliberateness of the violations and the impact on NRC's ability to accurately assess the receipt and control of byproduct material, these violations are categorized collectively in accordance with the Enforcement Policy as a Severity Level II problem. The current Enforcement Policy is accessible from the NRC's Web site.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4400 is considered for a Severity Level II problem. Because the violation is considered willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is not warranted for identification since the violation was NRC-identified. Credit is not warranted for corrective actions since delivery directly to the hospital continued until February 10, 2000, although the President/RSO was aware of the violation since at least June 7, 1999.

Therefore, to emphasize the significance of deliberate violations, the importance of identifying and correcting violations, and compliance with regulatory requirements, 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 amount of $8800, which is twice the base amount. 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. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

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 made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

  Sincerely,

/RA/ James L. Caldwell for
J. E. Dyer
Regional Administrator

Docket No. 030-14458
License No. 24-18087-01

Enclosure:  Notice of Violation and Proposed Imposition of Civil Penalty

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Biomedical Scanning Services, Inc.
St. Louis, Missouri		   Docket No. 030-14458
License No. 24-18087-01
EA-00-288

During an NRC review of licensed activities on March 3, 2000, and an investigation completed on December 15, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, May 1, 2000, 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:

1.   10 CFR 35.29(d) requires that a mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client's address of use.

Contrary to the above, on numerous occasions between October 1998 and February 10, 2000, the licensee ordered byproduct material to be delivered directly to St. Genevieve Memorial Hospital, St. Genevieve, Missouri, a client's address of use serviced by Biomedical Scanning Services, Inc.(010102)

2.   License Condition No. 14, dated December 23, 1997, states, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in its letter, dated September 29, 1997. Item A of the September 29, 1997 letter states, in part, that an authorized recipient will be present during all deliveries of byproduct material from the supplier.

Contrary to the above, on numerous occasions between December 23, 1997 and February 10, 2000, byproduct material was delivered by a nuclear pharmacy to the licensee's mobile van and an authorized recipient was not present during deliveries of byproduct material. (010202)
3.   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, be complete and accurate in all material respects.

Contrary to the above, on January 26 and March 3, 2000, the licensee deliberately provided information to the NRC that was incomplete or inaccurate in some respect material to the NRC as follows:
a.   During the January 26, 2000 inspection, the licensee provided incomplete information to an NRC inspector when the President/RSO was questioned about receipt of byproduct material and failed to inform the inspector that an authorized individual was not always present to receive material at the mobile van and that byproduct material was being ordered to be delivered directly to St. Genevieve Memorial Hospital (St. Genevieve), a client's address of use. Further, the President/RSO questioned the inspector about how Biomedical could arrange to receive unit doses at a client hospital and was advised by the inspector that a license amendment would be required.
b.   During the March 3, 2000 review, the licensee provided inaccurate information to the NRC inspector when the President/RSO was questioned as to whether he was previously informed that ordering byproduct material to be delivered directly to a client's address of use was a violation. The President/RSO stated to the inspector that he was not advised by the NRC until the January 26, 2000 inspection, that receiving byproduct material at St. Genevieve was a violation. However, during a June 7, 1999 telephone conversation, the President/RSO was informed by an NRC license reviewer that receiving byproduct material at a client's address of use was not allowed by the regulations.
c During the March 3, 2000 review, the licensee provided inaccurate information to the NRC inspector when the President/RSO was questioned about ordering byproduct material to be delivered directly to St. Genevieve. The President/RSO stated that ordering byproduct material to be delivered directly to St. Genevieve had been discontinued on January 26, 2000. The statement was inaccurate in that ordering byproduct material to be delivered directly to St. Genevieve was not discontinued until February 10, 2000. (010302)
The above information was material to the NRC in that it prevented the NRC from properly assessing the security and control of byproduct material.

This is a Severity Level II problem (Supplements VI and VII).
Civil Penalty – $8800

Pursuant to the provisions of 10 CFR 2.201, Biomedical Scanning Services (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 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. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. 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 in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 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 violation(s) 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.C.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 that 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: R. W. Borchardt, 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 made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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 21st day of February 2001.

1 The January 26, 2000 inspection, did not identify any violations of regulatory requirements. However, if the license had provided accurate information to the NRC during the January 26, 2000 inspection, the NRC would have cited violations for receiving material at the mobile van without an authorized individual present and for ordering material that was delivered directly to the hospital.

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