United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-02-131 - Plaza Nuclear Imaging

September 11, 2002

EA-02-131

Plaza Nuclear Imaging
ATTN: Dra. Frieda Silva
             Director
Call Box 7886 # 150
Guaynabo, Puerto Rico 00970

SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY-$3,000 (NRC INSPECTION REPORT NO. 52-25340-01/01-01 AND OFFICE OF INVESTIGATIONS REPORT 2-2001-024)

Dear Dra. Silva:

This refers to an investigation completed by the Nuclear Regulatory Commission's (NRC) Office of Investigations (OI) on May 14, 2002. The purpose of the OI investigation was to determine whether Plaza Nuclear Imaging (PNI) operated without required contamination monitoring devices. The investigation was conducted as a follow-up to NRC Inspection Report No. 52-25340-01/01-01, issued on September 6, 2001. Additional details from the investigation and inspection, and five apparent violations, were forwarded to you by letter of July 9, 2002. This letter also provided PNI the opportunity to either respond to the apparent violations in writing or request a predecisional enforcement conference. The NRC confirmed PNI's desire not to attend a predecisional enforcement conference, and by letter dated July 15, 2002, PNI provided its response to the apparent violations and addressed the causes and corrective actions to prevent recurrence.

Based on the information developed during the inspection and investigation, and the information in your July 15, 2002, response, the NRC has determined that five violations of regulatory requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding them are described in detail in the subject inspection report. The violations cited in Part I of the Notice involved: (1) the failure to detect radioactive contamination on wipe samples with a detector sufficient to measure 2000 disintegrations per minute, as required by 10 CFR 35.70(f); (2) the failure to survey for removable contamination once each week all areas where radiopharmaceuticals were routinely prepared for use, stored or administered, as required by 10 CFR 35.70(e); (3) the failure to test sealed sources for leakage at intervals not to exceed six months per 10 CFR 35.59(b)(2); and (4) the failure to monitor the external surfaces of incoming labeled packages for radioactive contamination as required by 10 CFR 20.1906(b)(1). An additional violation is cited in Part II of the Notice involving the failure to maintain complete and accurate records of the monitoring of incoming labeled packages, as required by 10 CFR 30.9.

No actual radiological consequences occurred as a result of the violations cited in the Notice. In addition, the potential consequences of the violations were low because of the type and quantity of radioactive material involved (i.e., unit doses of Technetium-99m and iodine doses in capsule form) and because PNI's surveys with a Geiger counter likely would have detected gross contamination. Thus, given their low safety significance, the violations cited in Part I of the Notice would normally be characterized at Severity Level IV in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. However, the NRC concluded that the violations in Part I of the Notice were due to the deliberate actions of the PNI Radiation Safety Officer (RSO). The NRC's regulatory program is based on licensees and their employees acting with integrity and candor in adhering to regulatory requirements. Based on this and in accordance with the Enforcement Policy, the NRC has concluded that these violations should be characterized at Severity Level III. Because of the interrelationship of the violations cited in Part I, the NRC also has concluded that these violations should be cited as one Severity Level III problem.

In its response of July 15, 2002, PNI agreed that the violations occurred as stated, but expressed its disagreement with the NRC's conclusion that the violations were deliberate. Instead, PNI indicated that the cause of the violations could be attributed to a failure to quickly resolve the equipment breakdowns and difficulties associated with the financial situation of the company, which caused the corrective action to become untimely. In addition, PNI requested information from the NRC on the amount of time that is allowed to correct a violation once it is identified.

The OI investigation thoroughly reviewed this matter, and the results were forwarded to PNI in our July 9, 2002, letter. In summary, OI concluded that the RSO knew of the requirements for contamination surveys, understood the requirements, and chose to proceed with conducting licensed activities in violation of NRC requirements from June 2000 until the NRC's intervention in August 2001. Avenues to resolve the matter in the short term were available to PNI, including consultation with the NRC, which may have led to an exemption or other administrative resolution while other short term and long term corrective actions could be taken to restore compliance. However, PNI chose not to pursue these avenues, and remained in non-compliance with regulatory requirements for an extended period of time. PNI's response of July 15, 2002, provided no new information to change the staff's conclusion regarding the deliberate actions of the RSO.

Regarding PNI's request for information, NRC licensees are required to comply with regulatory requirements at all times. Once a licensee recognizes a non-compliance, it must promptly take action to restore compliance and prevent its recurrence. In this case, the violation of 10 CFR 35.70(f) was initially identified during an NRC inspection on November 28, 1995, cited as a repeat violation in NRC Inspection Report 52-25340-01/98-01 dated August 7, 1998, and identified a third time resulting in this action. Corrective actions to restore compliance can include interim measures, such as the use of other equipment or methods to satisfy regulatory requirements, submitting a request for and subsequent NRC granting of a temporary exemption to certain requirements, or additional alternatives on a case-by-case basis. The interim corrective actions used in response to the June 2000 failure had already been identified as inadequate in Report 52-25340-01/98-01 and no other actions were taken. In summary, the responsibility to ensure compliance with regulatory requirements lies with the license holder.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III problem. Because the violations were willful, the NRC considered whether credit was warranted for the factors of Identification and Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy. Regarding the factor of identification, the NRC concluded that this issue was identified during our inspection of August 2001, and additional details were identified during the OI investigation. As such, credit was not warranted for the factor of Identification. Once the violations were identified to you by the NRC, your corrective actions included plans to purchase a second wipe test counter in August 2002, as an emergency backup, plans to calibrate the wipe test counter at appropriate intervals to assure that one is working and in calibration at all times, and the hiring of a consultant to assist troubleshooting technical problems with equipment. Based on this, the NRC concluded that credit was warranted for the factor of Corrective Action.

Therefore, to emphasize the importance of prompt identification of issues 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 base amount of $3,000 for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

An additional violation (Violation II.A) was identified and is cited in the enclosed Notice, involving the failure to maintain complete and accurate records of the monitoring of incoming labeled packages, as required by 10 CFR 30.9. Based on the low safety significance and the fact that this violation was not willful, this violation has been characterized at Severity Level IV in accordance with the Enforcement Policy.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved is adequately addressed on the docket in NRC Inspection Report No. 52-25340-01/01-01, your response of July 15, 2002, and in this letter. Therefore, you are not required to respond to the violations contained in this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (if you choose to provide one) 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library).

If you have any questions regarding this matter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety, at 404-562-4700.

Sincerely,

  /RA/

  Luis A. Reyes
Regional Administrator

Docket No. 030-33894
License No. 52-25340-01

Enclosures:
1.  Notice of Violation and Proposed Imposition Of Civil Penalty
2. NUREG/BR-0254 Payment Methods (Licensee only)


NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Plaza Nuclear Imaging, Inc.
Guaynabo, Puerto Rico
  Docket No. 30-33894
License No. 52-25340-01
EA-02-131

During an NRC inspection conducted on August 7, 2001, additional followup inspection completed on July 9, 2002, and an investigation completed by the NRC's Office of Investigations on May 14, 2002, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure 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:

1. Violations Assessed a Civil Penalty

  A.   10 CFR 35.70(f) requires, in part, that the licensee be able to detect radioactive contamination on each wipe sample of 2000 disintegrations per minute (dpm).

Contrary to the above, between June 2000 and August 7, 2001, the licensee was not able to detect radioactive contamination on each wipe sample of 2000 dpm. Specifically, the licensee was using a Geiger counter calibrated to measure radiation levels to quantify contamination levels, a method that did not enable the licensee to determine if it would detect contamination on wipe samples of 2000 dpm.

  B.   10 CFR 35. 70(e) requires that the licensee survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.

Contrary to the above, between November 2000 and August 7, 2001, the licensee failed to survey for removable contamination once each week all areas where radiopharmaceuticals were routinely prepared for use, administered or stored.

  C.   10 CFR 35.59(b)(2) requires, in part, that the licensee test its sealed sources for leakage at intervals not to exceed six months.

Contrary to the above, between November 2000 and August 7, 2001, an interval in excess of six months, the licensee failed to test its sealed sources for leakage.

  D.   10 CFR 20.1906(b)(1) requires that each licensee monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4

Contrary to the above, from June 2000 until August 7, 2001, the licensee failed to monitor the external surfaces of incoming labeled packages for radioactive contamination, the contents of which were not in the form of a gas or in special form as defined in 10 CFR 71.4.

This is a Severity Level III problem (Supplement VI).
Civil Penalty - $3,000

II..   Violation Not Assessed a Civil Penalty

  A.   10 CFR 30.9 requires that information provided to the Commission by a licensee or information required to be maintained by the Commission's regulations shall be complete and accurate in all material respects.

Contrary to the above, from November 2000 until August 7, 2002, the licensee failed to maintain complete and accurate records of its monitoring of incoming labeled packages. Records establishing the monitoring of incoming packages under 10 CFR 20.1906(b)(1) are required to be maintained by 10 CFR 20.2103(a), and are material to the NRC in that they provide indication of whether levels of radioactive contamination in excess of regulatory limits in incoming packages have been detected by the licensee.

This is a Severity Level IV violation (Supplement VII).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in NRC Inspection Report No. 52-25340-01/01-01, in your response of July 15, 2002, and in the letter transmitting this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region II within 30 days of the date of the letter transmitting this Notice.

Within 30 days of the date of this Notice, 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 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty, 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 any or all 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 payment of civil penalty should be addressed to Frank 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 II.

Should you choose to respond to the violation, 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, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 11th day of September 2002

 

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