EA-96-398 - New England Medical Center

November 13, 1996

EA 96-398

Ms. Mary Schneider
Administrative Director, Radiology
New England Medical Center
171 Harrison Avenue
Boston, Massachusetts 02111

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-01868/96-002)

Dear Ms. Schneider:

This letter refers to the NRC inspection conducted on September 24 and 25, 1996, at your facility in Boston, Massachusetts. The purpose of this inspection was to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements, and to review the circumstances surrounding the receipt of a package containing NRC licensed radioactive material by your staff and transportation of this package by taxi to the Department of Veterans Affairs Medical Center (DVAMC) also located in Boston, Massachusetts. During the inspection, apparent violations of NRC requirements were identified, and were described in the NRC inspection report transmitted with our letter dated October 23, 1996. On November 7, 1996, a Predecisional Enforcement Conference was held with you and other members of your staff to discuss the incident, apparent causes, and corrective actions to prevent recurrence. A copy of the Predecisional Enforcement Conference Report will be sent to you by separate correspondence at a later date.

Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that violations of NRC requirements occurred. These 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 first violation involves your failure to comply with 49 CFR 173.441(a) in that, you failed to assure that a package of radioactive material for shipment was prepared such that the radiation level did not exceed 200 millirem per hour at any point on the external surface of the package. Compliance with 49 CFR 173.44(a) is required by NRC regulations in 10 CFR 71.5(a). Specifically, on September 23, 1996, your medical physicist transported in the trunk of a taxi a package containing 44 millicuries of iridium-192 (15 seeds in a ribbon) to the DVAMC in Boston, and upon arrival of that package at the DVAMC, a survey of the package by the DVAMC staff indicated that the radiation level at the bottom of the package was 400 millirem per hour. The second violation involves your failure to perform, at NEMC prior to the transfer to the DVAMC, an adequate survey of the package as required by 10 CFR 20.1501 to assure compliance with exposure limits for members of the public in 10 CFR 20.1302. Although no exposure above 0.002 rem in one hour to a member of the public had occurred, it was fortuitous that the package was always handled in the upright position with the high exposure rates (400 mR/hr at contact and 40 mR/hr at one meter) emanating from the bottom of the package towards the ground and the bottom of the taxi cab trunk.

The NRC is particularly concerned with your failure to perform an adequate survey prior to transporting the package, because such failures have the potential to cause unnecessary exposure to members of your staff, the staff at the receiving facility, and members of the public while the package is in transport. Since these violations involved radiation levels in excess the NRC limit (although less than five times the limit), the violations are classified in the aggregate at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation or problem. Because New England Medical Center 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 action is warranted because your actions were both prompt and comprehensive. These actions included, but were not limited to: (1) creating a revised survey form for packages containing radioactive material; and (2) providing extensive training, to all staff who receive and ship packages containing radioactive material, in the procedure for surveying packages and use of the revised survey form.

Therefore, to emphasize prompt identification and comprehensive correction of violations when they exist, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant 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, its enclosure, and any response will be placed in the NRC Public Document Room (PDR).

Sincerely,

ORIGINAL SIGNED BY William F. Kane for Hubert J. Miller Regional Administrator

Docket No. 030-01868
License No. 20-03857-06

Enclosure: Notice of Violation

cc w/encls:
Commonwealth of Massachusetts

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NOTICE OF VIOLATION

New England Medical Center Boston, Massachusetts

Docket No. 030-01868 License No. 20-03857-06 EA 96-398

During an NRC inspection conducted on September 24 and 25, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," the violations are listed below:

A. 10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of usage, as specified in the NRC license, or on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.

49 CFR 173.441(a) requires, in part, with exceptions not applicable here, that each package of radioactive materials offered for transportation be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed 200 millirem per hour at any point on the external surface of the package.

Contrary to the above, on September 23, 1996, a package offered for transportation was not prepared for shipment such that radiation levels did not exceed 200 millirem per hour on the external surface of the package. Specifically, the licensee shipped a package containing 44 millicuries of iridium-192 by common carrier vehicle (not designated as exclusive use) and the radiation level measured at a point on the external surface of the package was approximately 400 millirem per hour. (01013)

B. 10 CFR 20.1501 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.

10 CFR 20.1302 requires, in part, that if an individual were continuously present in unrestricted areas, the dose from external sources would not exceed 0.002 rem in an hour.

Contrary to the above, as of September 23, 1996, the licensee did not make surveys to assure compliance with 10 CFR 20.1302, Dose limits for individual members of the public. Specifically, the licensee failed to adequately survey a package which was transported in a taxi cab from the New England Medical Center to the Department of Veterans Affairs Medical Center. Fortuitously, no exposures of personnel of greater than .002 rem in one hour had occurred. (01023)

These violations represent a Severity Level III problem (Supplements IV and V).

Pursuant to the provisions of 10 CFR 2.201, New England 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 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, or proprietary 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 disclosure of the information will create an unwarranted invasion of personal privacy or provide the confidential commercial or financial information).

Dated at King of Prussia, Pennsylvania
this 13th day of November 1996