EA-00-193 - St. Mary's Medical Center

October 27, 2000

EA-00-193

Steve Kern, Vice President
Professional Services
St. Mary's Medical Center
3700 Washington Avenue
Evansville, IN 47750

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 030-20812/2000-001 (DNMS))

Dear Mr. Kern:

This refers to the inspection conducted from August 2 through August 24, 2000, at St. Mary's Medical Center, Evansville, Indiana. This was a routine inspection to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. During the telephone exit meeting on August 24, 2000, the radiation safety officer (RSO) was informed of the results of the inspection and the report documenting the inspection was sent to you in a letter dated September 15, 2000.

In a telephone conversation on September 26, 2000, Mr. Geoffrey Wright of my staff informed you that the NRC was considering escalated enforcement for an apparent violation involving your Quality Management Program. Mr. Wright also informed you that we had sufficient information regarding the apparent violation and your corrective action to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you. You indicated that St. Mary's Medical Center did not believe that a predecisional enforcement conference or written response was needed. However, subsequent to the telephone conversation, St. Mary's Medical Center provided a written response, dated October 6, 2000.

Based on the information developed during the inspection and provided in your written response, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described below and in detail in the subject inspection report. The violation involves, from at least January 2000 to August 2, 2000, your staff's failure to prepare written directives prior to administering quantities of sodium iodide iodine-131 (greater than 30 microcuries, but less than 5 millicuries) for diagnostic whole-body imaging. The violation occurred as a result of the radiation safety officer misinterpreting the Quality Management Program requirements regarding written directives for procedures involving iodine-131. Through a review of records and discussions with your staff during the inspection, the violation did not appear to result in any misadministrations.

The failure is substantial, in that for at least a seven month period, written directives were not used when greater than 30 microcuries of iodine-131 were administered for diagnostic imaging. While no misadministrations occurred, the failure to have a written directive could have resulted in misadministrations due to a misunderstanding of the physician's order by the administering technologists. Therefore, in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) NUREG 1600, May 1, 2000, a substantial failure to implement the Quality Management Program that does not result in a misadministration results in a Severity Level III violation.

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 an escalated enforcement action 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.C.2 of the Enforcement Policy. Credit is warranted for corrective action. During the inspection, the RSO indicated that all future administrations of iodine-131 for diagnostic procedures will have a written directive signed and dated by an authorized user or an individual under the supervision of an authorized user prior to administration.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, 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. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violation, the corrective action taken to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report No. 030-20812/2000-001(DNMS). 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, its enclosure, and your response, if you choose to provide one, will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/
		J. E. Dyer Regional Administrator

Docket No. 030-20812
License No. 13-03226-04

Enclosure: Notice of Violation

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NOTICE OF VIOLATION
St. Mary's Medical Center Evansville, Indiana		Docket No. 030-20812 License No. 13-03226-04 EA-00-193

During an NRC inspection conducted from August 2 through August 24, 2000, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, May 1, 2000, the violation is listed below:

10 CFR 35.32(a) requires, in part, that each 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 quality management program must include written policies and procedures to meet, in part, the following specific objective: that, prior to administration, a written directive is prepared for any administration of quantities greater than 30 microcuries of sodium iodide iodine-131.

The licensee's written quality management program, dated September 14, 1994, Nuclear Medicine Section A1 requires, in part, that for the administration of a dose of Iodine-131 in quantities greater than 30 microcuries, a written directive be provided by an authorized user.

Contrary to the above, from at least January 2000 to August 2, 2000, the licensee administered quantities of iodine-131 in excess of 30 microcuries without written directives being provided by authorized users.

This is a Severity Level III violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report No. 030-20812/2000-001(DNMS). 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 III, 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 made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

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