EA-99-294 - Fox Chase Cancer Center
November 30, 1999
Vice President, Business Development
and Regulatory Affairs
Fox Chase Cancer Center
7701 Burholme Avenue
Philadelphia, PA 19111
|SUBJECT:||Notice of Violation and
NRC Inspection Report 030-03026/99-01
Dear Ms. Harsche:
This refers to the NRC inspection conducted on November 1, 2, 5, and 9, 1999, at your facility in Philadelphia, Pennsylvania, to determine whether activities authorized by your NRC broad-scope license were conducted safely and in accordance with requirements. During the inspection, a violation of NRC requirements was identified. In a telephone conversation on November 24, 1999, you informed Dr. M. Shanbaky of my staff that Fox Chase Cancer Center did not believe that a predecisional enforcement conference, nor a written response, was needed, prior to the NRC deciding on appropriate enforcement action. The NRC agrees that it has sufficient information to take the action described below.
Based on the information developed during the inspection, the NRC has determined that one violation of NRC requirements occurred. The violation, which is described in the enclosed Notice of Violation (Notice) and inspection report, involves your Radiation Safety Committee approving certain physicians to use radioactive material without those physicians meeting all of the training requirements set forth in the NRC regulations. As a result of this violation, the NRC issued a Confirmatory Action Letter to you on November 12, 1999, confirming your commitment to take appropriate correct actions to address this violation.
As a broad scope medical licensee, you have the authority to authorize physicians to use licensed material in or on humans. At the same time, you have the responsibility for ensuring that these physicians first meet all of the training criteria set forth in NRC regulations prior to authorizing such use. That responsibility was not met since your Medical Isotope Sub-Committee of the Radiation Safety Committee approved 16 radiologists to use of radiopharmaceuticals for various medical procedures, even though 13 of those physicians did not meet the training requirements.
The NRC recognizes that this violation did not result in any actual safety consequences since only one dose was administered by an unqualified physician and that administration appears to have been performed properly. Nonetheless, the potential existed for misuse of the radiopharmaceuticals, which could have been detrimental to the patients and technical staff involved in such dose administrations. Therefore, given the number of physicians who did not meet the training requirements, and the potential safety consequences, the violation is categorized at Severity Level III violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, as described during the inspection, as well as in the Confirmatory Action Letter (CAL), were considered prompt and comprehensive. These actions include, but are not limited to, (1) issuance of a memorandum from your Radiation Safety Officer to the physicians who did not satisfy all of the training requirements, which revoked their authorizations to use material; (2) plans to establish and implement procedures for RSC review and approval of authorizations; and (3) training of the RSC staff in NRC requirements.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action that may increase the NRC inspection effort at your facility.
The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence, were already described adequately during the inspection, in the NRC November 12, 1999, CAL, and in this letter. Therefore, you are not required to respond to this letter unless the description therein 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 and its enclosure, and your response (if any) will be placed in the NRC Public Document Room (PDR).
|Original Signed by:
James T. Wiggins for
|Hubert J. Miller
Docket Nos. 030-03026
License Nos. 37-02766-01
Notice of Violation
Nancy D. Moldofsky, Radiation Safety Officer
Commonwealth of Pennsylvania
NOTICE OF VIOLATION
|Fox Chase Cancer Center
New Brunswick, New Jersey
|Docket No. 030-03026
License No. 37-02766-01
During an NRC inspection conducted on November 1, 2, 5, and 9, 1999, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, the violation is listed below:
Condition 11.B of NRC License No. 37-02766-01, Amendment No. 54, requires that the physicians that are designated to use licensed material in or on humans meet the training criteria established in 10 CFR Part 35, Subpart J and be designated by the licensee's Radiation Safety Committee. 10 CFR Part 35.930 (Subpart J), in part, requires the authorized user of radiopharmaceuticals in 10 CFR 35.300 to be a physician who is certified by The American Board of Radiology in Radiology, Therapeutic Radiology, or Radiation Oncology.
Contrary to the above, on September 23, 1999, the Medical Isotope Committee of the Radiation Safety Committee approved 13 physicians for therapeutic use of radiopharmaceuticals in 10 CFR Part 35.300 and these physicians were not certified by the American Board of Radiology in Radiology, Therapeutic Radiology or Radiation Oncology. (01013)
This is a Severity Level III violation (Supplement VI).
The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence were adequately described during inspection, and are already adequately addressed on the docket in the letter transmitting this Notice, as well as in the NRC Confirmatory Action letter issued on November 12,, 1999. 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 I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.
Dated this 30th day of November 1999