EA-96-526 - Sheffield Clinic

March 21, 1997

EA 96-526

Subhash Khullar, M.D.
Sheffield Clinic
39150 Dequindre Road
Sterling Heights, MI 48310

SUBJECT:

NOTICE OF VIOLATION AND DEMAND FOR INFORMATION (NRC Office of Investigations Report No. 3-96-004)

Dear Dr. Khullar:

This refers to an investigation conducted from April 3 through December 20, 1996, by the NRC Office of Investigations (OI). The purpose of the investigation was to review the circumstances surrounding the licensed material found at a facility once operated by you under the name of Nuclear and Radiologic Imaging Physicians, P.C. (NRIP), in Livonia, Michigan. A synopsis of the OI report is enclosed.

Based upon the information developed during the investigation, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice). The NRC Form-314, "Certificate of Disposition of Materials," signed by you on February 26, 1990, as president of NRIP, specified that all material in NRIP's possession had been disposed of by return to the appropriate vendors, and as a result of this statement, NRC staff terminated License No. 21-24472-01 ¹.

In January 1996, nearly six years after the license was terminated, two calibration sources containing radioactive materials (cesium-137 and barium-133) licensed by the NRC were found abandoned in the building which housed NRIP between 1985 and 1990. You failed to appropriately dispose of all licensed materials prior to requesting termination of the license, even though you indicated on NRC Form-314 that you had appropriately disposed of all licensed materials. At a minimum, your actions in this matter constitute careless disregard of NRC requirements.

This violation is of regulatory significance because, when an NRC Form 314, "Certificate of Disposition of Materials," is submitted, the submitting party attests that all licensed materials have been properly disposed of and that all licensed activities have ceased. In this case, two calibration sources remained on the premises for some six years after you attested that all NRC-licensed material had been disposed of appropriately. By providing inaccurate information on a material document (i.e., a document required by the NRC), you prevented the NRC from accurately reviewing and processing the termination of your license. Specifically, your license would not have been terminated had the status of the sources been known to the NRC. Because this violation is willful, it is of very significant regulatory concern and has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level II.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,000 is considered for a Severity Level II violation. However, in consideration of the facts of this specific case, including the age of the violation, and after consultation with the Director, Office of Enforcement, I have been authorized not to propose a civil penalty in this case.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response.

In addition to the response required above, and in light of the fact that you are currently named as an authorized user on Byproduct Material License No. 21-04080-01, the Commission requires further information in order to determine that the Commission can have reasonable assurance that, in the future, licensed activities will be conducted in accordance with the Commission's requirements. Accordingly, in order to determine whether further enforcement action should be taken to assure your future compliance with NRC requirements, you are hereby required, pursuant to Sections 161c, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's requirements in 10 CFR 2.204, to submit to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, the following information, in writing, under oath or affirmation:

1. Explain why the calibration sources were found at the Livonia facility in 1996 when the NRC Form-314, "Certificate of Disposition," signed by you on February 26, 1990, indicated that licensed materials had been disposed of properly.

2. Explain why you indicated to the OI investigator that NRIP assets (calibration sources) could not be removed from the premises because of ongoing bankruptcy proceedings when the bankruptcy proceedings did not begin until a voluntary petition for a Chapter 7 bankruptcy (Case No. 91-02854-G) was filed with the clerk of the court on March 14, 1991, a full year after you signed the NRC Form-314. In addition, please explain why NRC should not conclude that you violated 10 CFR 30.9 by knowingly providing false information to the NRC investigator.

3. State why the NRC should have confidence that, in the future, you will adhere to NRC requirements, and will assure that information provided by you to the Commission, as well as NRC-required records, will be complete and accurate in all material respects.

The response to the above shall be submitted within 30 days of the date of this letter. After reviewing your response to this Notice and Demand for Information, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

Questions concerning this Demand for Information should be addressed to James Lieberman, Director, Office of Enforcement, who can be reached at (301) 415-2741.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.

Sincerely,

Original signed by Cynthia D. Pederson for A. Bill Beach Regional Administrator

License No. 21-24472-01 (Terminated)
Docket No. 030-18655

Enclosure: As stated

---

NOTICE OF VIOLATION

Subhash Khullar, M.D. d.b.a. Nuclear and Radiologic Imaging Physicians Livonia, Michigan

Docket No. 030-18655 License No. 21-24472-01 EA 96-526

During an NRC investigation conducted from April 3 through December 20, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee be complete and accurate in all material respects.

10 CFR 30.36 required, in 1990, that each licensee notify the Commission in writing under §30.6 and request termination of the license when the licensee decides to terminate all activities involving materials authorized under the license. Among other things, the notification and request for termination of the license was required to include the reports and information specified in paragraphs (c)(1)(iv) of this section. Paragraph (c)(1)(iv) required the licensee to submit a completed Form NRC-314, which certifies information concerning the disposition of materials.

Contrary to the above, in order to terminate its license, the licensee certified, on a Form NRC-314 dated February 26, 1990, that all byproduct material had been disposed of when, in fact, all byproduct material had not been disposed of. Specifically, in January 1996, two calibration sources containing byproduct material were found at the facility previously occupied by the Nuclear and Radiological Imaging Physicians, P.C., 31500 Schoolcraft, Livonia, Michigan.

This is a Severity Level II violation (Supplements VI and VII).

Pursuant to the provisions of 10 CFR 2.201, Subhash C. Khullar, M.D., is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include the reason for the violation, or, if contested, the basis for disputing the violation. 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 other action may be taken. Where good cause is shown, consideration will be given to extending the response time.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Lisle, Illinois
this 21st day of March 1997

---

^1. The termination request was initiated in accordance with a Settlement Agreement reached in conjunction with your request for a hearing in response to an August 23, 1989 Order which suspended License No. 21-24472-01. The Order was issued inpart because of your failure to respond to a July 3, 1989 Notice of Violation.