EA-97-406 - St. Peter's Medical Center

September 25, 1997

EA 97-406

Mr. John Grangeia, Vice President
Professional Services
St. Peter's Medical Center
254 Easton Avenue
New Brunswick, New Jersey 08903-0591

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-02502/97-001)

Dear Mr. Grangeia:

This refers to the NRC inspection conducted on August 14, 1997, at your facility. The inspection was conducted to review the activities authorized by your license, and to determine if they were conducted safely and in accordance with NRC requirements. During the inspection, four apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated September 4, 1997. On September 18, 1997, a predecisional enforcement conference was conducted with you, and other St. Peter's Medical Center staff, to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be sent to you by separate correspondence.

Based on the information developed during the inspection and enforcement conference, the NRC has determined that four violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice). Two of the violations involve (1) failure to maintain control of licensed material, specifically, a cesium-137 source which was inadvertently taken by a contract physicist to another hospital in New Jersey; and (2) failure to immediately report to the NRC Operations Center that the radioactive source was lost, transported through unrestricted areas, and discovered at another hospital. The violations are described in detail in the Notice and the subject inspection report.

The actual incident occurred in November 1995 when the contract physicist came to your facility and used his portable dose calibrator to measure the activity of your 38 cesium-137 brachytherapy sources. The last source that was calibrated was inadvertently left in the portable dose calibrator and was transported by the contract physicist to St. Francis Hospital, in Trenton, New Jersey. The source was not discovered until the next morning when the contract physicist started to set-up his measuring system to calibrate sources at St. Francis Hospital. After you became aware that this event occurred, you failed to report this matter to the NRC as required. Two other violations of NRC requirements contributed to this event, namely (1) failure to inventory sources after the sources were returned to the shielded storage location (such an inventory would have indicated that one of the sources was missing); and (2) failure to make adequate surveys to evaluate the presence of potential radiological hazards during and after your source calibration procedures.

The actual radiological consequences of this incident appear to be minimal, because the source was recovered within 24 hours, was transported by a contract physicist in his private car, was stored in a radiologically restricted area after arrival at St. Francis Hospital. Moreover, persons in unrestricted areas were exposed to radiation emanating from the source for only short periods of time. However, this failure to maintain control of licensed material could have had more significant radiological consequences since the portable measuring equipment containing the source was not properly shielded and the dose rate near the equipment case was approximately 50 mR/hr.

The violations demonstrate a significant lack of oversight and attention to licensed activities that collectively represent a breakdown in control of these activities. As such, the violations have been classified in the aggregate as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy in effect at the time this violation occurred, a base civil penalty in the amount of $2,500 is considered for a Severity Level III problem that occurred in November 1995. 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 both prompt and comprehensive. These actions, which were described during the enforcement conference, and/or during the inspection, included, but were not limited to a review of policies and procedures related to handling brachytherapy sources, source inventories and radiological surveys, by your Radiation Safety Officer with your physics staff, immediately following the incident and annually, thereafter. Also, with respect to the failure to report this incident to the NRC within 30 days of discovery, as required, you indicated, during the enforcement conference, that based on your current understanding of NRC expectations in this area, all similar incidents will be reported to the NRC. Also, you indicated that if there is any doubt about whether an incident is reportable, you will immediately contact the NRC for clarification.

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.

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, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely,

ORIGINAL SIGNED BY WILLIAM L. AXELSON for Hubert J. Miller Regional Administrator

Docket No. 030-02502
License No. 29-07566-01

Enclosure: Notice of Violation

cc w/encl:
State of New Jersey

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NOTICE OF VIOLATION

St. Peter's Medical Center New Brunswick, New Jersey

Docket No. 030-02502 License No. 29-07566-01 EA 97-406

During an NRC inspection conducted on August 14, 1997, 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:

A. 10 CFR 20.1802, in part, requires that the licensee control and maintain constant surveillance of licensed material that is not in storage.

Contrary to the above, on November 9, 1995, the licensee did not control and maintain constant surveillance of a 14.7 millicurie cesium-137 source. That source, which was not in storage, was located in the portable dose calibrator of the licensee's contract physicist, and was inadvertently taken from the licensee's facility and transported to St. Francis Hospital in Trenton, New Jersey.

B. Condition 22 of License No. 29-07566-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in the licensee's application dated October 11, 1993.

Item 10.15(14) of the application dated October 11, 1993, titled Sealed Source Management states, in part, that " The sealed sources for brachytherapy are stored in a leaded safe in a secured room in Radiation Therapy. An inventory is maintained for these sealed sources. The inventory is updated any time a source(s) is removed from or returned to the safe."

Contrary to the above, on November 9, 1995, a cesium-137 source was removed from safe for source calibrations performed by the contract physicist, and the inventory was not updated.

C. 10 CFR 20.1501, in part, requires, that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, on November 9, 1995, the licensee did not make surveys to assure compliance with 10 CFR 20.1301(A)(2), which limits radiation dose in any unrestricted area to 0.002 rem in any one hour. Specifically, the licensee did not make surveys of the contract physicist's portable dose calibrator, and as a result, the licensee did not determine that a cesium-137 source was inadvertently left in the calibrator. The dose in unrestricted areas from the unshielded source was estimated to be 0.005 rem per hour.

D. 10 CFR 20.2201(a)(1)(i) requires the licensee to report to the NRC Operations Center by telephone immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity greater than 1000 times the quantity specified in appendix C to part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas.

Contrary to the above, on November 10, 1995, the licensee did not report to the NRC Operations Center by telephone, after it became known to the licensee that one of its cesium-137 sources was in an unplanned location and that exposure could have resulted to persons in unrestricted areas as the unshielded source was carried through the hallways, stairwells, elevators and the parking lots of the 2 hospitals. The Appendix C quantity for cesium-137 is 10 microcuries. The cesium-137 source was 14.7 millicuries, 1470 times greater than the Appendix C quantity.

These violations are categorized in the aggregate as a Severity Level III problem (Supplement IV).

Pursuant to the provisions of 10 CFR 2.201, St. Peter's Medical Center 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 25th day of September 1997