United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-00-177 - Sioux Valley Hospital Association

November 30, 2000

EA-00-177

Pamela Shute, Chief Clinical Officer
Sioux Valley Hospital Association
1100 South Euclid Avenue
Sioux Falls, South Dakota 57117-5039

SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-03249/00-01)

Dear Ms. Shute:

This refers to the predecisional enforcement conference conducted on October 26, 2000, in the NRC's Region IV office in Arlington, Texas. The conference was held to review apparent violations of NRC requirements in the implementation of your quality management program that may have contributed to a misadministration. The misadministration was identified and reported to the NRC on June 16, 2000, as a result of our inspection. The inspection findings were discussed with you during a telephonic exit briefing on September 25, 2000.

Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that two violations of NRC requirements occurred. The first violation is the most significant and it is cited in the enclosed Notice of Violation (Notice). It involves multiple failures to implement your quality management program from calendar year 1997 through April 4, 2000. Specifically, the technologists routinely failed to verify, prior to administering byproduct material, that the specific details of the administration were in accordance with the written directive. In addition, there were several instances where the written directives were not adequately prepared. These failures contributed to 66 recordable events and one medical misadministration that occurred at your facility. The misadministration occurred on April 4, 2000, and involved administering 4.26 millicuries (mCi) of sodium iodide I-131 instead of the intended 100 mCi of sodium iodide I-131 which the written directive specified. Shortly after the incorrect dose was administered, a technologist observed that the written directive called for 100 mCi of sodium iodide I-131 to be administered, and changed the written directive to 4 mCi thinking that the written directive was in error.

It was later determined by the authorized user, as documented in the hospital's June 16, 2000, letter that, based on the whole body scan of the patient, the 100 mCi therapy dose was not needed. However, the circumstances surrounding the violation indicate that there were weaknesses in the implementation of your quality management program. As discussed above, your technologists routinely failed to verify, before administering the byproduct material, that the dose was in accordance with the written directive, contrary to NRC requirements. In addition, it was determined that the 66 recordable events were caused by failures to write a written directive or to complete the written directive with all the required information. Based on information your staff provided during the predecisional enforcement conference, the significance of these weaknesses was mitigated for therapy administrations because the hospital's practice had been for the authorized user to be present each time a therapy dose was administered. As a result, the authorized user was normally present to ensure that his directions were followed. However, your staff acknowledged that this practice was not followed for the intended 100 mCi therapy dose which resulted in a misadministration. Based on the circumstances, 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 $2,750 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.C.2 of the Enforcement Policy. The NRC determined that you were deserving of credit for your Corrective Actions. Your corrective actions included counseling the technologist involved in changing the written directive, providing training to all the technologists to ensure administrations were in accordance with written directives, and improving procedures and forms to ensure that written directives are followed by the technologists. In addition, we noted that, based on the NRC's previous inspection (reference NRC Inspection Report No. 030-03249/99-01 dated March 8, 2000, and Sioux Valley Hospital's April 7, 2000 response to the Notice of Violation), Sioux Valley Hospital had conducted a comprehensive review of its Quality Management Program and, at the time of our June 2000 inspection, was in the process of implementing an Administrative Action Plan to improve its Quality Management Program.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, 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.

In addition, the NRC identified a second violation involving the failure to evaluate and take specified actions to a recordable event, within 30 days after discovery of the event. This violation was classified at Severity Level IV, and is cited in the enclosed Notice.

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 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library).

Sincerely,

/RA/

Ellis W. Merschoff
Regional Administrator

Docket No. 030-03249
License No. 40-12378-01

Enclosure: Notice of Violation

cc w/Enclosure:
South Dakota Radiation Control Program Director

Chairman, Board of Directors
Sioux Valley Hospital Association
1100 South Euclid Avenue
Sioux Falls, South Dakota 57117-5039


NOTICE OF VIOLATION

Sioux Valley Hospital Association
Sioux Falls, South Dakota
Docket No. 030-03249
License No. 40-12378-01
EA-00-177

During an NRC inspection conducted on June 15 through September 25, 2000, 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 35.32(a) requires, in part, that the 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.

Item 1 of the licensee's written quality management program dated January 13, 1991, required that an authorized user must sign and date a written directive prior to the administration of a radiopharmaceutical of any dosage of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.

Item 3 of the licensee's written quality management program dated January 13, 1991, required that the licensed user or designee will verify, before administering the byproduct material, that the specific details of the administration are in accordance with the written directive. The radiopharmaceutical, dosage, and route of administration will be confirmed by the person administering the radiopharmaceutical to verify agreement with the written directive, that is, the dosage will be measured in the dose calibrator and the results compared with the prescribed dosage in the written directive.

Contrary to the above, on about 66 occasions from calendar year 1997 through April 4, 2000, an authorized user failed to sign and date a written directive prior to the administration of sodium iodide I-131 in quantities greater than 30 microcuries. In addition, on multiple occasions during this time period, a licensed user or designee failed to verify, before administering the byproduct material, that the specific details of the administration were in accordance with the written directive. (01013)

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

B.   10 CFR 35.32(c) requires that the licensee evaluate and respond, within 30 days after discovery of a recordable event, to each recordable event by: (1) assembling the relevant facts including the cause; (2) identifying what, if any, corrective action is required to prevent recurrence; and (3) retaining a record in an auditable form for three years, of the relevant facts and what corrective action, if any, was taken.

Contrary to the above, the licensee failed to evaluate and respond, within 30 days after the discovery of several recordable events, to each recordable event by: (1) assembling the relevant facts including the cause; (2) identifying what, if any, corrective action is required to prevent recurrence; and (3) retaining a record in an auditable form for 3 years, of the relevant facts and what corrective action, if any, was taken. Specifically, after discovering 66 recordable events by March 20, 2000, as of June 15, 2000, a period in excess of 30 days, the licensee failed to assemble the relevant facts including the cause, identify corrective action to prevent recurrence, and retain a record of the relevant facts and the corrective action taken. (02014)

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

Pursuant to the provisions of 10 CFR 2.201, Sioux Valley Hospital Association is hereby required to submit a written statement or explanation 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). 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 or severity level, (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.

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, this response shall be submitted under oath or affirmation.

Because your response will be made available to the Public, to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public 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).

Dated this 30th day of November 2000.

 

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