EA-99-257 - Clara Maass Medical Center

April 26, 2000

EA 99-257

Thomas Biga
Executive Director
Clara Maass Medical Center
1 Franklin Avenue
Belleville, NJ 07109

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-02467/99-01 and Investigation Report No. 1-1999-031)

Dear Mr. Biga:

This refers to the NRC inspection conducted on September 27 – 28, 1999, at your facility in Belleville, New Jersey. The inspection was conducted to review your licensed activities as they relate to radiation safety. During the inspection, two apparent violations of NRC requirements were identified. The apparent violations were described to your staff during an exit meeting at the conclusion of the inspection on September 28, 2000. In a telephone conversation on April 19, 2000, Dr. Mohamed Shanbaky of my staff informed Mary Ellen Klein, of your staff, that the NRC had sufficient information regarding the violations and your corrective actions to make an enforcement decision without a predecisional enforcement conference or a written response from you. Ms. Klein indicated that Clara Maass Medical Center did not believe that a predecisional enforcement conference or written response was needed.

Based on the information developed during the inspection, both violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

The most significant violation (Item 1 in the Notice) involved the treatment of patients with your High Dose Rate (HDR) afterloaded after the source was replaced, without first checking the source to ensure that the source strength was consistent with the value provided by the manufacturer. Although some quality assurance checks were performed on the HDR unit prior to use, your medical physicist was unable to verify the manufacturer's source strength certification because the dosimetry system used to verify (calibrate) the source unit was not available. This was a violation of your facility's procedures that require a check of the source strength after each installation. Although there were no actual consequences in this case, since the source strength was subsequently checked and was consistent with the manufacturer's values, the failure to check the source prior to use on patients could have resulted in administration of an incorrect dose to the patient, possibly much higher than the prescribed dose for treatment.

Therefore, given the potential consequences that could result from use of an unverified HDR source, the first violation is categorized as a Severity Level III violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. The NRC Office of Investigations (OI) also performed an investigation to determine whether the medical physicist's use of the HDR unit for patient treatment prior to the calibration was a deliberate violation of your facility's procedures. Based on the investigation, there is insufficient evidence to substantiate that the violation was willful. A copy of the OI synopsis is attached.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action 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 actions is warranted because your corrective actions were considered prompt and comprehensive, once the violation was identified by the NRC. These actions include, but are not limited to: (1) a complete review of the HDR program by the Medical Physicist and the Radiation Oncology Manager; (2) a mandatory inservice for all staff associated with the HDR program on the requirements of the license; (3) the development of a "job specifics checklist" for newly hired medical physicists that includes instruction on all requirements of the NRC license; and (4) revision of HDR quality assurance forms highlighting items that must be completed prior to treating patients with the HDR unit.

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 subject you to increased inspection effort.

The second violation (Item 2 in the Notice) involved an individual functioning as the medical physicist for the HDR program at your facility without the individual being listed on your license as authorized to do so. As a result, the NRC was unable to review the individual's qualifications prior to the time the individual assumed those duties. After the second violation was identified, you submitted an amendment request to name the individual as the new medical physicist. We reviewed your request and found the individual was qualified for the position. The amendment was granted on September 29, 1999. Therefore, the second violation has been classified as a Severity Level IV violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, are adequately addressed on the docket 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 enclosures, will be placed in the NRC Public Document Room (PDR).

		Sincerely,
		/RA/ James T. Wiggins Acting For
		Hubert J. Miller Regional Administrator

Docket No. 030-02467
License No. 29-03163-03

Enclosure:  Notice of Violation

cc w/encls:
Commonwealth of Pennsylvania

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ENCLOSURE 1 NOTICE OF VIOLATION
Clara Maass Medical Center Belleville, NJ		Docket No. 030-02467 License No. 29-03163-03 EA 99-257

During an NRC inspection conducted on September 27-28, 1999, as well as an investigation conducted by the NRC Office of Investigations between October 13, 1999 and March 24, 2000, 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 violations are listed below:

10 CFR 35.21(a) requires that the licensee, through the Radiation Safety Officer, ensure that radiation safety activities are being performed in accordance with approved procedures. The licensee's procedures for use of the high dose rate remote afterloader (HDR) are described in an enclosure to a letter dated September 22, 1997, and were approved by License Condition No. 27.

	1.	The enclosure to the letter dated September 22, 1997 states, in part, in Section No. 8, "Operating and Calibration Procedures," that the HDR Source Output (Activity) Check will be performed after each source installation before patient treatment is resumed. Contrary to the above, on July 19, 1999, the licensee, through its Radiation Safety Officer, failed to ensure that radiation safety activities were being performed in accordance with the above procedures. Specifically, on that date, the licensee treated a patient with the HDR after a new source was installed, without first performing a source output (activity) check. (01013) This is a Severity Level III violation (Supplement VI).
	2.	The enclosure to the letter dated September 22, 1997, identifies, in Section No. 3, "Proposed Users for High Dose Rate," three authorized physicists and encloses curriculum vitae for each listed physicist. On January 19, 1998, NRC issued Amendment No. 38 of License No. 29-03163-03 authorizing the possession and use of a high dose rate remote afterloader and identifying, in Condition No. 12, the three authorized medical physicists. Contrary to the above, prior to September 28, 1999, an individual performed the duties of the authorized medical physicist without being listed as an authorized medical physicist on the license. (01024) This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed on the docket in the NRC letter transmitting this 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 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.

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

Dated this 26th day of April 2000