EA-02-072 - Advanced Medical Imaging and Nuclear Services

October 22, 2002

EA 02-072

Devendra K. Amin, M.D.
Advanced Medical Imaging and Nuclear Services
3729 Easton-Nazareth Highway
Easton, PA 18045

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $43,200 (NRC Inspection Report 03035594/2001002 and NRC Office of Investigations Report No. 1-2001-034)

Dear Dr. Amin:

The enclosed Notice of Violation (Notice) and Proposed Imposition of Civil Penalty is being issued to Advanced Medical Imaging and Nuclear Services (AMINS) based on deliberate misconduct resulting in violations of NRC requirements, including use of licensed materials and conduct of licensed activities, between March and November 2001, without an Authorized User (AU) and Radiation Safety Officer (RSO), as well as creating inaccurate records that are required to be maintained by the NRC. Specifically, your Vice President (VP) and your Chief Operating Officer (COO) operated the AMINS facility with the knowledge that the facility did not have an AU and RSO in deliberate violation of NRC regulations. Also, the patient records created and maintained by AMINS were inaccurate, since they named a physician as the AU, when in fact, the individual was not employed by your company and was not acting as the AU.

These violations were identified during an NRC inspection conducted between November 30, 2001, and December 17, 2001, and during a subsequent investigation by the NRC Region I Office of Investigation (OI). Given the significance of using licensed material and performing licensed activities for an extended period without an AU and RSO, the NRC, prior to the completion of the inspection and investigation, issued a Confirmatory Action Letter (CAL) on December 3, 2001, confirming that you would cease all licensed activities until you retained an AU and RSO. Immediately after your license was amended to add a new AU and RSO, you proceeded to conduct activities without the supervision of the AU as required by 10 CFR 35.25. On December 14, 2001, the NRC issued an Order Suspending your license. Further, the NRC issued a Demand for Information (DFI) on December 21, 2001, requesting, in part, your basis as to why your license should not be revoked. After you responded to the Order and DFI on January 2 and 9, 2002, requesting that the license be reinstated and not revoked, the NRC informed you that a sufficient basis had not been provided to lift the suspension at that time, including the fact that the OI investigation was ongoing.

After the OI investigation was completed, the inspection report and factual summary of the OI investigation were forwarded to you on May 21, 2002, and the findings were discussed with you during a predecisional enforcement conference held on June 17, 2002. The discussion included the violations, their causes, and your corrective action. At the conference, you acknowledged that the violations had occurred, but you denied that the violations were the result of deliberate actions by your employees.

Notwithstanding your denial, the NRC maintains that deliberate violations of NRC requirements occurred. In reaching these conclusions, the NRC considered the facts that: (1) the VP prepared the NRC license application in October 2000, with the aid of a consulting physicist, and he listed an individual (a physician) as the AU and RSO on the application; however, the individual named as the AU and RSO was never employed by AMINS and never performed the duties of the AU or RSO at AMINS; (2) from June 2001 through November 2001, AMINS staff listed that individual as the AU of record when it ordered and administered radiopharmaceuticals on approximately 590 occasions; (3) in October 2001, a consulting physicist conducted an audit that revealed that the duties of the AU/RSO had not been performed, and he briefed you regarding the problem at the end of the audit, yet NRC licensed activities continued until the NRC inspection on November 30, 2001; (4) the VP, when interviewed by an OI investigator, admitted that he knew the facility was required to have an AU and RSO and knew as early as June 2001 that not having an AU and RSO was a problem, but he did not take action to correct the situation; and (5) both the VP and COO admitted to the OI investigator that there were financial considerations associated with keeping the facility open.

Deliberate violations are a very serious concern to the NRC because the NRC regulatory program relies, in part, on the honesty and integrity of NRC licensees and their employees. As such, deliberate violations cannot be tolerated. Given the deliberate wrongdoing at AMINS for an extended period by senior managers in your organization, the NRC gave serious consideration to revocation of your NRC license. However, after careful consideration of all the factors in this case, the NRC has decided not to revoke your license for the following reasons: (1) your staff cooperated with the inspection and investigation; (2) you provided timely responses to the CAL, dated December 3, 2001, as well as the subsequent Order and DFI; (3) you have implemented corrective actions to preclude recurrence of the violations, including the addition of qualified individuals to your staff to perform the functions of the AU and RSO; and (4) the NRC is issuing Orders Prohibiting Involvement in Licensed Activities to your VP and COO, precluding them from any involvement in NRC licensed activities until December 14, 2002 (one year from the date your license was suspended by NRC Order).

Nonetheless, because of the deliberate nature of the violations and the level of the management involvement with the violations, the violations are classified as a Severity Level II problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. In accordance with the current version of the Enforcement Policy, a base civil penalty in the amount of $4,800 is considered for a Severity Level II violation or problem. Because the violations were willful in nature, 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 for identification is not warranted because the violations were identified during an inspection of your facility and your staff had prior opportunities to identify the problem to the NRC. Credit for corrective action is warranted because your corrective actions subsequent to the Order and DFI, and at the time of the conference, were considered comprehensive. These actions included, but were not limited to: (1) hiring a qualified AU and RSO and submitting a request to amend the license; (2) providing clarification of the responsibilities and expectations of the AU and the RSO, including frequency of site visits and audits; (3) providing authority to the RSO to shut down operations if necessary to ensure compliance; and (4) providing further instruction to personnel regarding NRC requirements related to radiation safety and compliance.

Application of the civil penalty assessment process would normally result in a civil penalty of $4,800. However, Section VII.A.3 of the Enforcement Policy provides that, notwithstanding the normal civil penalty assessment process, the NRC may exercise discretion and propose daily civil penalties for a significant violation that continues for more than one day. After considering the egregiousness of these violations, the level of management involved, the economic benefit that you received by operating without an AU and RSO, and the failure to correct the problem even after your consultant's findings on October 3, 2001; and to emphasize the significance of ordering and administering byproduct material to human patients without the benefit of a physician authorized user and a radiation safety officer, the NRC has decided that consideration of daily civil penalties is appropriate in this case. While the NRC could issue a $4,800 civil penalty for every day that these violations occurred, after careful consideration, the NRC has decided that it is appropriate to issue: (1) a base civil penalty amount of $4,800 for the occurrence of the violations between March 2001 and October 3, 2001; and (2) additional civil penalty in the base amount of $4,800 for each of the eight weeks that the violations continued even after the consultant raised the issue on October 3, 2001. As a result, a total civil penalty of $43,200 is proposed. Further, issuance of this Notice of Violation and Proposed Imposition of Civil Penalty 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. In your response, you may reference any previous correspondence that is applicable to this case to avoid repetitive submissions. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

For the reasons described above, including your broad corrective actions, the NRC is lifting the suspension of your license as of the date of this letter.

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.

Questions concerning this Notice may be addressed to Frank Congel, Director, Office of Enforcement. Mr. Congel can be reached at telephone number (301) 415-2741.

		Sincerely,
		/RA/
		Carl J. Paperiello Deputy Executive Director for Materials, Research and State Programs

Docket No. 030-35594
License No. 37-30603-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl: Commonwealth of Pennsylvania

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Advanced Medical Imaging and Nuclear Services Easton, PA

License No. 37-30603-01 Docket No. 030-35594 EA 02-072

During an NRC inspection conducted at Advanced Medical Imaging and Nuclear Services (AMINS) between November 30, 2001 and December 17, 2001, and a subsequent investigation by the NRC Office of Investigations (OI), the report of which was issued on March 29, 2002, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), 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 violations and associated civil penalty are set forth below:

I.	VIOLATIONS ASSESSED A CIVIL PENALTY
	A.	10 CFR 35.11 requires, in part, that a person shall not use byproduct material for medical use except in accordance with a specific license or under the supervision of an authorized user as provided in 10 CFR 35.25. Contrary to the above, from June 2001 to November 30, 2001, a Nuclear Medicine Technologist (NMT) used byproduct material for patient diagnosis on approximately 590 occasions, and the use by the NMT was not in accordance with a specific license. In addition, the NMT was not under the supervision of an authorized user.
	B.	10 CFR 35.21(a) requires that a licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in daily operation of the licensee's byproduct material program. Contrary to the above, from about March 2001 to November 30, 2001, the licensee conducted licensed activities, including ordering and administering radiopharmaceuticals on approximately 590 occasions, and during that time, the licensee had not appointed a Radiation Safety Officer responsible for implementing the radiation safety program, to ensure that activities were being performed in accordance with approved procedures and regulatory requirements in daily operations of the licensee's program.
	C.	10 CFR 30.9(a) requires, in part, that information required by license conditions to be maintained by the licensee, shall be complete and accurate in all material respects. License condition 15.A of the NRC license for AMINS requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in various documents, including the license application dated October 20, 2000. Item 10, Attachment 10.6 of the NRC license application for AMINS dated October 20, 2000, requires that written records will be made that identify the Authorized User when ordering radioactive materials. Contrary to the above, on November 30, 2001, information required to be maintained by the licensee was not complete and accurate in all material respects. Specifically, all records of radioactive materials ordered between March 2001 and November 2001 indicated that the Authorized User who ordered the radiopharmaceuticals was Dr. Brij Mohan Gupta (Dr. Mohan). These records were not accurate in that Dr. Mohan was not employed by the licensee as an Authorized User. This statement was material because an Authorized User was required by the license and by NRC regulations for supervision of the administration of radiopharmaceuticals to patients.
		These violations represent a Severity Level II problem (Supplement IV). Civil Penalty - $43,200
II.	VIOLATIONS NOT ASSESSED A CIVIL PENALTY
	A.	10 CFR 35.50(b)(4) requires, in part, that a licensee test each dose calibrator for geometry dependence upon installation over a range of volumes and volume configurations for which it will be used. Contrary to the above, from June 2001 to November 2001, the licensee's tests of its dose calibrator for geometry dependence were not over the range of volumes and volume configurations for which it was used. Specifically, the licensee tested the dose calibrator using a 30 cubic centimeter (cc) vial and did not test the dose calibrator for a volume configuration used (i.e., a 3-cc syringe). This is a Severity Level IV violation (Supplement VI)
	B.	10 CFR 35.50(b)(2) requires, in part, that a licensee test the dose calibrator for accuracy upon installation and at least annually by assaying at least two sealed sources containing different nuclides. Contrary to the above, from March 2001 until November 30, 2001, the licensee's test of the dose calibrator for accuracy did not include assaying at least two sealed sources containing different nuclides; rather, the licensee tested its dose calibrator with only one sealed source of one radionuclide. This is a Severity Level IV violation (Supplement VI)

Pursuant to the provisions of 10 CFR 2.201, Advanced Medical Imaging and Nuclear Services 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. 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, 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, 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 30 days of the date of this Notice, 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.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 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: F. Congel, 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 I.

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 22 day of October 2002