EA-02-205 - Medical Providers Capital Network
February 11, 2003
Medical Providers Capital Network
894 Marcon Boulevard, Suite 190
Lehigh Valley Industrial Park III
Allentown, PA 18109
|SUBJECT:||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $3,000 (NRC INSPECTION REPORT NUMBER 03033816/2002001 AND OFFICE OF INVESTIGATIONS REPORT 1-2002-008)|
Dear Mr. Levin:
This letter refers to an NRC inspection conducted on February 26 and 27, and March 11, 2002, at the Medical Providers Capital Network (MPCN) facility in Allentown, Pennsylvania and Lakewood, New Jersey. The inspection report was sent to you on November 4, 2002. In addition, an investigation was conducted by the NRC's Office of Investigations (OI) to determine if MPCN knowingly engaged in activities under its license without a Radiation Safety Officer (RSO). The OI investigation, which was subsequently expanded to include a review of a concern regarding the falsification of reports, was completed on August 21, 2002. A summary of the investigative findings was sent to you on November 4, 2002. OI found that MPCN willfully failed to provide adequate oversight of licensed activities at its work sites, and that a former Authorized User (AU) and RSO, and the Chief Nuclear Medicine Technologist (NMT), knowingly falsified records with respect to the performance of AU/RSO oversight of licensed activities at the facilities.
A predecisional enforcement conference was held with you as the representative from MPCN on November 14, 2002, to discuss the apparent violations, their causes, and your corrective actions to prevent the violations from recurring. During the conference, you contended that the violations were not deliberate, and indicated that you thought you were never out of compliance because you believed that you had an AU and RSO at all times.
Notwithstanding your position, based on the information developed during the inspection and investigation, and the information provided by you during the conference, the NRC has determined that three violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding them are described in detail in the subject inspection report. The violations involved: (1) the failure of your AU/RSO to perform monthly visits to your facilities to review the use of byproduct material between March 2000 and December 2001, despite his knowledge that such visits were required; (2) the creation of false records indicating that the AU/RSO had visited your facilities on a monthly basis during that period; and (3) your receipt, possession and use of a byproduct material without the supervision of an AU/RSO between January 14, 2002, and March 4, 2002.
With respect to the first two violations, the NRC determined that the AU/RSO failed to perform all of the required monthly visits; however, the Chief NMT created records for the AU/RSO to sign indicating that the AU/RSO had made monthly visits to the facilities. The AU/RSO signed these records despite the knowledge by both the Chief NMT and the AU/RSO that the visits had not all occurred. The record keeping violation is material to the NRC because your staff used the records to conclude that oversight of the supervised user was being provided, and the NRC used the records to determine compliance with the license requirement.
With respect to the first and third violation, the medical use of byproduct material requires the supervision provided by an AU/RSO to ensure that patient doses are administered properly. The requirements in revised 10 CFR 35, effective October 24, 2002, continue to require that radioactive material may only be used for medical purposes by, or under the supervision of an Authorized User. In the revised 10 CFR Part 35, licensees are given flexibility in how supervised individuals are evaluated. The Authorized User is best suited to determine which tasks may be delegated to a supervised individual. The licensee is responsible for ensuring that tasks delegated by the Authorized User receive the proper instruction and supervision.
Similar to the first violation, the third violation involved the failure of either individual listed on the license to perform the duties of the AU. The three violations have been collectively categorized as a Severity Level III 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 $3,000 is considered for a Severity Level III violation or problem. Because at least two of 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 by the NRC. Credit is warranted for your corrective actions which include, but are not limited to: (1) appointment of a new RSO and AU; (2) documentation of the statement from the new AU that he would assume the responsibilities of the AU; and, (3) delegation of some AU duties to the Chief NMT.
Therefore, to emphasize the importance of workers' compliance with the regulations and of 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 $3,000 for this 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. 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.
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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library).
|James T. Wiggins Acting For
|Hubert J. Miller
Docket No. 03033816
License No. 37-30213-01
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
State of New Jersey
Commonwealth of Pennsylvania
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Medical Providers Capital Network Allentown, PA||Docket No. 03033816
License No. 37-30213-01
During an NRC inspection conducted on February 27, February 28, and March 11, 2002, as well as a subsequent investigation by NRC Office of Investigations, three 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 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:
|A.||10 CFR 35.25(b)(3) requires, in part, that a licensee
that permits the preparation of byproduct material for medical use
by an individual under the supervision of a physician who is an authorized
user, as allowed by 35.11(c), shall require the supervising physician/authorized
user to periodically review the work of the supervised individual
as it pertains to preparing byproduct material for medical use and
the records kept to reflect that work.
Condition 15 of NRC License No. 37-30213-01, states that the licensee shall conduct its program among other things, in accordance with the statements and procedures contained in the application dated March 15, 1995, and a letter dated January 12, 1999. Item 10, subsection "Supervision" of the application, requires that one of the authorized users be physically present at least once every 30 days to review the supervised individual's use of radioactive material at a mobile location to meet the requirements of 10 CFR 35.25 (a)(3). In the January 12, 1999, letter, the licensee states that this license condition will apply to the Ocean Cardiology site in Lakewood, New Jersey.
Contrary to the above, from March 2000 to December 2001, at the Lakewood, New Jersey facility, an authorized user was not physically present at least once every 30 days to review the individual's use of radioactive material.
|B.||10 CFR 30.9(a) requires, in part, that information required by the
Commission's license conditions to be maintained by the licensee shall
be complete and accurate in all material respects.
Condition 15 of NRC License No. 37-30213-01, states that the licensee shall conduct its program among other things, in accordance with the statements and procedures contained in the application dated March 15, 1995, and a letter dated January 12, 1999. Item 10, subsection "Supervision" of the application, requires that one of the authorized users be physically present at least once every 30 days to review the supervised individual's use of radioactive material at a mobile location to meet the requirements of 10 CFR 35.25 (a)(3), and that a record be kept for NRC review. In the January 12, 1999 letter, the licensee states that this license condition will apply to the Ocean Cardiology site in Lakewood, New Jersey.
Contrary to the above, between March 2000 and December 2001, information that was required by the Commission's license condition was not complete and accurate in all material respects. Specifically, records required by license condition 15 for 30-day visits by the authorized user to review the supervised user's use of byproduct material at the Ocean Cardiology facility in Lakewood, New Jersey, between March 2000 and December 2001, were not accurate in all material respects. These records were not accurate in that, 14 memoranda, required to be maintained by the licensee, stated that the former authorized user had observed operations at the Lakewood facility on certain dates. However, the former authorized user did not visit the facility on some of the dates stated in the memoranda. These records were material because the licensee used them to conclude that adequate oversight of the supervised user was being provided and the NRC used them to determine compliance with the license requirement.
|C.||Condition 12 of the NRC license issued to the licensee, which was
in effect at the time of the inspection in February 2002, required
that licensed material be used by, or under the supervision of, Douglas
Harr, M.D. or Kenneth Levin, M.D.
Contrary to the above, between January 14, 2002 and March 4, 2002, the licensee received, possessed and used technetium-99m, a byproduct material, without the supervision of either Dr. Harr or Dr. Levin. Specifically, licensed material was used by individuals other than Dr. Harr or Dr. Levin, and these individuals were not under the supervision of Dr. Harr or Dr. Levin.
These violations are characterized as a Severity Level III problem (Supplement VI).
Civil Penalty - $3,000
Pursuant to the provisions of 10 CFR 2.201, Medical Providers Capital Network 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, EA 02-205" 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, EA02-205" 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 http://www.nrc.gov/reading-rm/adams.html (the Public Reading Room). 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 11th day of February 2003