EA-97-245 - Mountainside Hospital
Mr. David McCarthy
Director of Clinical Services
Bay and Highland Avenue
Montclair, New Jersey 07042
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-02470/97-001)
Dear Mr. McCarthy:
This refers to the NRC inspection conducted on April 30 and May 1, 1997, at your facility in Montclair, New Jersey, to determine whether activities authorized by your NRC licenses were conducted safely and in accordance with NRC requirements. One apparent violation of NRC requirements was identified during the inspection. The inspection report was sent to you on June 4, 1997. On June 25, 1997, a Predecisional Enforcement Conference was conducted with you and members of your staff to discuss the violation, its cause, and your corrective actions. A copy of the enforcement conference report will be forwarded to you by separate correspondence.
Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involves the failure to follow your Quality Management Program (QMP) for your High Dose Rate Afterloading (HDR) treatment program in that certain activities required to be performed by your authorized Medical Physicist listed on the license were, at times, being performed by an individual other than the Medical Physicist listed on the NRC license. Specifically, from January 1997 to May 1997, for several HDR patients' treatments, the calculations of the required treatment times and verification of the accuracy of the treatment input parameters were performed by an individual other than the Medical Physicist listed on the license.
In addition to the violation, one of the requirements of NRC Bulletin 93-01, issued in 1993 following a serious HDR event at a facility in Pennsylvania, is that an authorized user and the Radiation Safety Officer (RSO) or the Medical physicist must be present during each High Dose Rate Afterloader (HDR) treatment. There is only one individual who is named both the RSO and also the Medical Physicist on your NRC license. During the inspection, you stated that since January 1995, you used physicists other than the Medical Physicist named on the license, to be present during HDR treatments to meet the NRC Bulletin. Also, you indicated that since January 1997, some of the treatment plans were performed by an individual who is not authorized by the NRC license as a medical physicist. You further indicated that at times, the individuals, while in the general vicinity of the treatment areas, were not physically present for the treatment. At the conference, you indicated that since the inspection, the Medical Physicist named on the license has been present for all HDR treatments.
Given the potential safety consequences from improper use of the HDR, this violation has been categorized in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600; at Severity Level III.
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 escalated enforcement actions within the last two years, 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 action is warranted because they were both prompt and comprehensive. These actions, which were noted in the inspection report, in your response to a Confirmatory Action Letter issued on May 5, 1997, and/or at the conference, included, but were not limited to the following: (1) commitment to have your RSO/Medical Physicist (authorized by your NRC license) and the authorized user present for each HDR treatment; (2) reviewing all HDR treatment plans not performed by the medical physicist; (3) revising the QMP to include supervision of all treatment plans not performed by the medical physicist; and (4) revising the QMP to require that for each HDR treatment, RSO/Medical Physicist authorized by the NRC license and the authorized user to be physically present as described in NRC Bulletin 93-01.
Therefore, to encourage prompt identification and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in a civil penalty.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. 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 and its enclosure, will be placed in the NRC Public Document Room (PDR).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-02470
License No. 29-03297-02
Enclosure: Notice of Violation
State of New Jersey
Mountainside Hospital Docket No. 030-02470 Montclair, New Jersey License No. 29-03297-02 EA 97-245
During an NRC inspection conducted on April 30 and May 1, 1997, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violation is listed below:
10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
The licensee's written Quality Management Program (QMP) for the administration of High Dose Rate Afterloader (HDR) therapy dated, July 27, 1994, requires, in part, in Sections 4.5 and 4.6, that the Medical Radiation Physicist will calculate the required treatment time using the appropriate computer program, and before delivering the first treatment, the Medical Radiation Physicist will verify the accuracy of the computer-generated treatment parameters with regard to the input data on the treatment console.
License Condition 11.B of License No. 29-03297-02 specifies by name the Medical Physicist for the facility.
Contrary to the above, on certain occasions as of May 1, 1997, the Medical Physicist did not calculate the required treatment time using the appropriate computer program, and did not verify the accuracy of the computer-generated treatment parameters with regard to the input data on the treatment console before delivering the first treatment. Specifically, from January 1997 to May 1997, for several HDR patients' treatments, the calculations of the required treatment times and verification of the accuracy of the treatment input parameters were performed by an individual other than the Medical Physicist named on the license.
This is a Severity Level III violation (Supplement V).
Pursuant to the provisions of 10 CFR 2.201, Mountainside Hospital, 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 I, 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 for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not 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 King of Prussia, Pennsylvania
this 27th day of June 1997