EA-02-106 - Avera McKennan Hospital

October 4, 2002

EA-02-106

Mr. Fredrick W. Slunecka
Regional President
Avera McKennan Hospital
800 East 21^st Street
P.O. Box 5045
Sioux Falls, South Dakota 57117-5045

SUBJECT:

NOTICE OF VIOLATION (NRC INVESTIGATION REPORT 4-2001-053)

Dear Mr. Slunecka:

This refers to NRC investigation 4-2001-053 conducted by the NRC's Office of Investigations (OI) and completed on April 29, 2002. The purpose of the investigation was to determine whether there was a deliberate violation of NRC requirements associated with a contamination event which occurred on October 4, 2001, at Freeman Community Hospital in Freeman, South Dakota. On June 6, 2002, my staff informed you that the NRC had identified an apparent, deliberate violation of requirements associated with this incident, and that the NRC was considering escalated enforcement action in accordance with its enforcement policy. The apparent violation involved the use of radioactive material in the Freeman Community Hospital kitchen, an area where food was prepared and stored.

On July 12, 2002, a closed, predecisional enforcement conference was conducted with Avera McKennan Hospital personnel at the hospital in Sioux Falls, South Dakota. Avera McKennan Hospital acknowledged the violation, but denied that its nuclear medicine technologist committed a deliberate violation of NRC requirements. You stated at the conference that the technologist was under pressure from Freeman Community Hospital personnel and was attempting to serve the needs of a patient. You stated that the technologist made an error in judgment in using the hospital kitchen to heat a vial of technetium-99m when the hot plate in the Avera McKennan Hospital mobile lab would not work. You also characterized this incident as a system failure in that the wrong radiopharmaceuticals were loaded onto the vehicle that day, and the equipment in the vehicle was not working.

Based on the information that we obtained during the investigation, and our consideration of the information that you provided at the conference, we have determined that a violation of NRC requirements occurred. Furthermore, we agree that the violation was not committed deliberately in that it does not appear that either of the technologists involved in this incident made a conscious decision to be in violation of NRC requirements at the time of the incident. Nonetheless, keeping radioactive materials and food separate is so fundamental to good radiation protection practices that the NRC finds careless disregard for the involved requirements in the actions of the technologists who made this decision.

The violation is described in the enclosed Notice of Violation (Notice). Briefly, the violation involves heating a vial containing approximately 250 millicuries of technetium-99m on a kitchen stove where Freeman Community Hospital personnel were preparing meals for patients. The vial broke when being removed from the stove, creating a contamination incident. Fortunately, the spill was contained and there was no significant potential for spread of contamination or radiation exposures of kitchen personnel. Nonetheless, given the fact that the violation did result in a contamination incident, and was representative of careless disregard for requirements, the NRC has categorized this violation 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 $3,000 is considered for a Severity Level III violation. Because your facility has been the subject of escalated enforcement actions within the last 2 years,⁽¹⁾ the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Although the violation was revealed by the contamination incident, Avera McKennan Hospital went beyond the obvious in assessing and addressing the root causes of the incident. As discussed below, you addressed not only the actions of the technologists, but the system failures that contributed to this incident. Thus, the hospital is deserving of identification credit in this case. Avera McKennan Hospital's corrective actions included immediate actions to contain the spill, prevent others from becoming contaminated, and cleaning up the area. Other corrective actions included addressing this incident with all nuclear medicine technologists, issuing appropriate action to the two technologists who were involved in this incident, prohibiting technologists from preparing radiopharmaceuticals in facilities visited by the mobile lab, and developing a comprehensive checklist to assure that the mobile lab is loaded with the correct materials and that all equipment is working before it travels to other facilities. Based on these corrective actions, the hospital is deserving of corrective action credit. This results in no civil penalty being assessed.

Therefore, to encourage prompt identification, and prompt and comprehensive correction of violations, 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 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 your letter dated October 31, 2001 and 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, its enclosure, and any response you choose to make 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/
		Ellis W. Merschoff Regional Administrator

Docket No.: 030-11252
License No.: 40-16571-01

Enclosure: Notice of Violation

cc w/Enclosure: South Dakota Radiation Control Program Director

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NOTICE OF VIOLATION

Avera McKennan Hospital Sioux Falls, South Dakota

Docket No. 030-11252 License No. 40-16571-01 EA-02-106

During an NRC investigation completed April 29, 2002, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

License Condition 16-A requires the licensee to comply with the statements, representations and procedures of the licensee's application dated March 17, 1992. Item 10.4 of the license application dated March 17, 1992, "Safe use rules," incorporates into the license NRC Regulatory Guide 10.8, Revision 2, Appendix I, "Model Rules for Safe Use of Radiopharmaceuticals," dated August 1987. Model Rule Number 6 states, "Do not store food, drink, or personal effects in areas where radioactive material is stored or used."

Contrary to the above, on October 4, 2001, a licensee employee took a vial containing approximately 250 millicuries of technetium-99m into the kitchen of Freeman Community Hospital where food was being prepared, and heated the vial on a kitchen stove adjacent to where Freeman Community Hospital personnel were preparing meals for patients.

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 Avera McKennan Hospital's October 31, 2001 letter to the NRC and the letter transmitting this Notice of Violation. 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, 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.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, any response you choose to submit shall be submitted under oath or affirmation.

Because any response you choose to submit 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), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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 are required to post this Notice within two working days.

Dated this 4^th day of October 2002

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¹ On June 14, 2002, a Notice of Violation with a $3,000 civil penalty was issued for an unauthorized administration of radiopharmaceuticals to a nuclear medicine technology student.