EA-99-245 - St. Peter's Community Hospital

November 5, 1999

EA 99-245

Mr. Rick Monk
Vice President Information Services
St. Peter's Community Hospital
2475 Broadway
Helena, Montana 59601

SUBJECT:

NRC INSPECTION REPORT 030-10917/99-01 AND NOTICE OF VIOLATION

Dear Mr. Monk:

On October 5, 1999, the NRC completed an inspection of your nuclear medicine program. The purpose of the inspection was to review activities conducted under Byproduct Materials License 25-12453-02. A preliminary exit briefing was conducted at the conclusion of the onsite portion of the inspection with you; Martie L. Moore, R.N., Risk Manager; and Dan Owens, Administrative Director of Radiology. Subsequently, on October 5, a final telephonic exit briefing was conducted with you and your staff.

During the October 5 exit briefing, we informed you that the NRC was considering escalated enforcement for a violation involving a failure to secure from unauthorized removal or access licensed material in unrestricted areas. Further, we informed you that the NRC had sufficient information regarding the violation and your corrective actions to make an enforcement decision without a predicisional enforcement conference or a written response. You and your staff agreed that no further relevant information was available. As such, the NRC is making its final enforcement decisions on that violation.

Based on the information developed during the inspection and the information provided by your staff during a telephone conversation on September 15, 1999, the NRC has determined that two violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice). The first violation is the most significant and involved a failure to secure from unauthorized removal or access licensed materials that had been stored in unrestricted areas. Specifically, between January 1998 and August 1999, millicurie quantities of byproduct material were delivered to your facility and left unattended, and unsecured, in a public hallway adjoining the receiving department.

The inspectors determined that receiving personnel handled byproduct material shipments in the same manner as all other incoming packages and did not recognize the significance of not maintaining surveillance over radioactive materials. In this case, the actual risk to members of the general public was limited in that: 1) the activity of each shipment was relatively low, 2) receipts of material were infrequent, and 3) dose rates at surface of each were low due to internal package shielding. However, the NRC considers the failure to control byproduct material to be of significant concern because of the potential for members of the public to receive unintended and possibly significant radiation exposures. Therefore, this violation has been categorized 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, a base civil penalty in the amount of $5,500 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last 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 is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included modifying receipt practices and procedures to ensure licensed material was delivered to the nuclear medicine department where it would be controlled, and training receiving department personnel on the new receipt procedures.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The second violation involved the failure to apply for and receive a license amendment prior to establishing a new area of use within your facility, and it is categorized at Severity Level IV. The inspectors determined that from May 21, 1996, to September 3, 1999, byproduct material was routinely used in the stress lab for nuclear cardiology studies. This area had not been identified as an area of use in your license application or prior amendment requests.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken, and the date when full compliance will be achieved, is already adequately addressed on the docket in Inspection Report 030-10917/99-01 and the licensee's letter dated October 4, 1999. 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).

Should you have any questions concerning this inspection or the enclosed report, please contact Ms. Linda Howell at (817) 860-8213 or Mr. Richard Leonardi, Jr. at (817) 860-8187.

		Sincerely,
		/s/
		Ellis W. Merschoff Regional Administrator

Docket No.: 030-10917
License No.: 25-12453-02

Enclosure:  Notice of Violation

cc w/enclosures:
Montana Radiation Control Program Director

 

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ENCLOSURE 1

NOTICE OF VIOLATION

St. Peter's Community Hospital Helena, Montana

Docket No. 030-10917 License No. 25-12453-02 EA 99-245

During an NRC inspection conducted September 3 through October 5, 1999, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A.

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Contrary to the above, on multiple dates between January 1998 and August 1999, the licensee did not secure from unauthorized removal or limit access to millicurie quantities of iodine-131 located in a hallway adjoining the receiving department, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material (01013). This is a Severity Level III violation (Supplement VI).

B.

10 CFR 35.13(e) requires, in part, that a licensee apply for, and receive, a license amendment before adding or changing areas of use identified in the application or on the license. Contrary to the above, from May 21, 1996 to September 3, 1999, the licensee used byproduct material in a cardiac stress lab, and the area was not identified as an area of use in the license application. The licensee added this area of use on May 21, 1996, and as of September 3, 1999, the licensee had failed to apply for and receive a license amendment authorizing this area of use. This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in Inspection Report 030-10917/99-01, and the licensee's letter dated October 4, 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 IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, 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, 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).

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

Dated this 5th day of November 1999