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EA-03-092 - Deaconess HospitalAugust 29, 2003 EA-03-092 Linda White
Dear Ms. White: This refers to the inspection conducted on April 7, 2003, with continued NRC in-office review through May 13, 2003. The purpose of the inspection was to review the circumstances, root and contributing causes, and proposed corrective actions related to the administration of a 421 microcurie dosage of iodine-131(I-131) sodium iodide to a minor patient on March 28, 2003. The results of the inspection were transmitted to you on June 13, 2003, and identified three apparent violations of NRC requirements. In our letter transmitting the inspection report, we provided Deaconess Hospital the opportunity to address the apparent violations identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. In a letter, dated July 10, 2003, Deaconess Hospital provided a response to the apparent violations and in a letter, dated August 13, 2003, clarification to the response was provided. Based on the information developed during the inspection and the information that you provided in your letters, dated July 10 and August 13, 2003, 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. On March 28, 2003, Deaconess Hospital staff ordered and administered 421 microcuries of I-131 sodium iodide to a patient instead of the 4.5 microcuries prescribed by the authorized user, resulting in a medical event. The violation involved the failure to order 4.5 microcuries of I-131 sodium iodide as directed by the authorized user, to have a written directive dated and signed by an authorized user prior to the administration of 421 microcuries of I-131 sodium iodide and to administer a dosage within 20 percent of the prescribed dosage range for a thyroid uptake study using I-131 sodium iodide. Although the failure to have a written directive and follow the direction of an authorized user was an isolated event, the violation is a significant safety issue, since the NRC medical consultant could not rule out the possibility of long term consequences and recommended that the patient's progress be followed for the foreseeable future. The medical consultant's report was provided to you in our letter, dated June 13, 2003. 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 $3000 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. Credit is warranted for corrective actions that included: (1) providing in-service training to the nuclear medicine technologists and the radiologists regarding this medical event, the use of written directives, verifying that the dosage to be administered and the prescribed dosage are in agreement, and NRC regulations; (2) replacing the written policy for capsule and liquid thyroid uptake scans with two policies, one for adults and one for children; (3) routinely using only I-123 sodium iodide for thyroid uptake and imaging studies; (4) developing a standardized order form for liquid I-131 sodium iodide uptake doses that includes information on the patient's weight and age and faxing the form to the pharmacy after a telephone order has been placed; and (5) providing the commercial nuclear pharmacy with an updated list of typical dosage ranges, including ranges for I-131 sodium iodide. 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 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 the licensee's July 10 and August 13, 2003, responses. Therefore, you are not required to respond to this letter unless the description in your response 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 enclosure, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC also includes significant enforcement actions on its Web site at www.nrc.gov; select What We Do, Enforcement, then Significant Enforcement Actions.
Docket No. 030-01580 Enclosure: Notice of Violation
NOTICE OF VIOLATION
During an NRC inspection conducted on April 7, 2003, with continued NRC review through May 13, 2003, 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: 10 CFR 35.27(a) requires a licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user to require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material. 10 CFR 35.40(a) requires that a written directive be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 30 microcuries, any therapeutic dosage of unsealed byproduct material, or any therapeutic dose of radiation from byproduct material. 10 CFR 35.63(d) requires that unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent. Contrary to the above, on March 28, 2003, technologists, individuals under the supervision of the licensee's authorized user, failed to follow the authorized user's verbal instructions to order 4.5 microcuries of I-131 sodium iodide when a technologist ordered 400 microcuries of I-131 sodium iodide; failed to have a written directive that was dated and signed by an authorized user before administering 421 microcuries of I-131 sodium iodide to a patient; and used a dosage of I-131 sodium iodide that was not within the prescribed dosage range when a technologist administered 421 microcuries instead of the prescribed 4.5 microcuries. 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 the licensee's July 10 and August 13, 2003, responses. However, Deaconess Hospital is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description in your response 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; EA-03-092," 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, 801 Warrenville Road, Suite 255, Lisle, IL 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation. 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 NRC's document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. 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. Dated this 29th day of August 2003.
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