EA-96-071 - Washington County Memorial Hospital

May 2, 1996

EA 96-071

Mr. Rodney M. Coats, Chief Executive
Officer and Executive Director
Washington County Memorial Hospital
911 North Shelby
Salem, IN 47167

Dear Mr. Coats:

SUBJECT:

NOTICE OF VIOLATION AND ENFORCEMENT CONFERENCE (NRC INSPECTION REPORT NO. 030-33168/96001(DNMS))

This refers to the special safety inspection conducted at Washington County Memorial Hospital (WCMH) from January 25 to February 21, 1996, to review the circumstances concerning an administration of NRC-licensed material (nominally 16 millicuries (592 MBq) of iodine-131). On December 22, 1995, WCMH informed the NRC that on December 7, 1995, a patient received a therapeutic dosage of iodine-131 and at the time of the administration WCMH did not have a physician designated as an authorized user for therapeutic dosages of sodium iodide-131. The inspection found that the physician responsible for administering the dosage on December 7, 1995, met some, but not all, of the NRC training requirements to use unsealed byproduct material for therapeutic administrations. A copy of the inspection report was mailed to WCMH on March 15, 1996, and a predecisional enforcement conference was held at WCMH on April 4, 1996.

Based on the information developed during the inspection and the information presented at the predecisional enforcement conference, the NRC has determined that several violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances of the violations are described in detail in the inspection report.

Information provided by representatives of WCMH at the April 4, 1996 conference disclosed that the physician met the majority of the training requirements specified in 10 CFR 35.930. However, he lacked the training specified in 10 CFR 35.930(b)(2) to be qualified to use therapeutic dosages of iodine-131. Specifically, he observed the therapeutic use of iodine-131 during his training, but he did not actually use the material under the supervision of an authorized user as required by the NRC. Further, the WCMH Radiation Safety Committee did not review the physician's qualifications in either diagnostic or therapeutic nuclear medicine prior to allowing the physician to use NRC-licensed material. Also, a written directive was not prepared prior to the iodine-131 therapeutic administration on December 7, 1995. Additionally, WCMH did not inform the NRC when physicians authorized to use therapeutic dosages of iodine-131 were no longer affiliated with the hospital.

The violations are attributed to a lack of understanding of NRC regulations and the requirements of the NRC license by those responsible for implementing the NRC approved radiation safety program at WCMH. Some members of the WCMH staff recognized that the administration of a therapeutic dosage of iodine-131 would be the first time the procedure was attempted since June 1993, when the NRC issued the license to WCMH. Neither the physician who authorized the procedure nor the nuclear medicine technologist questioned whether WCMH met all of the regulatory requirements prior to performing the procedure. Also, the RSO was not informed of the plan to perform the procedure. The violations may have been averted had a questioning attitude been applied to a procedure that had not been performed at WCMH. Also, senior management, the Radiation Safety Officer (RSO), and members of the Radiation Safety Committee (RSC) were not sufficiently knowledgeable of the NRC approved process for authorizing individuals to use NRC-licensed materials.

Fortuitously, the procedure was accomplished without complication. Nevertheless, it is incumbent upon each NRC licensee to ensure that all NRC requirements are met in order to protect the health and safety of the public, and in this case the patients of WCMH. The administration of a therapeutic dosage of iodine-131 on December 7, 1995, represents the performance of NRC-licensed activities by a technically unqualified person, and is categorized as a Severity Level III violation in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. The remaining violations cited in the enclosed Notice are categorized at Severity Level IV.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. Since your facility has not been the subject of a previous NRC escalated enforcement action, 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 was warranted for the following corrective actions: admonishing the individuals involved for their failure to adhere to NRC requirements; and, amending the NRC license to withdraw the authority to use unsealed byproduct materials for therapeutic administrations. The NRC also recognizes that WCMH voluntarily informed the NRC of the incident. Therefore, to encourage prompt and comprehensive corrective actions, I have decided not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, the enclosed Notice, and your response if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-33168
License No. 13-26497-01

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

Washington County Memorial Hospital Salem, Indiana

Docket No. 030-33168 License No. 13-26497-01 EA 96-071

During an NRC inspection conducted from January 25 to February 21, 1996, 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. Condition No. 9.C, Amendment No. 1, of NRC Materials License No. 13-26497-01 authorized Washington County Memorial Hospital to use unsealed byproduct material for medical use pursuant to 10 CFR 35.300.

10 CFR 35.930(b)(2) requires, in part and with certain exceptions which are not pertinent here, that the licensee shall require the authorized user of radiopharmaceuticals in 10 CFR 35.300 to be a physician who has supervised clinical experience under the supervision of an authorized user at a medical institution that includes:

(i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and
(ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.

Contrary to the above, on December 7, 1995, a patient was administered 16 millicuries (582 MBq) of iodine-131, an NRC-licensed material in 10 CFR 35.300, and the physician did not have the supervised clinical experience under the supervision of an authorized user at a medical institution as described in 10 CFR 35.930(b)(2). Specifically, the physician did not use iodine-131 under the supervision of an authorized user for the above described purposes; rather, he observed the performance of these procedures. (01013)

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

B. 10 CFR 35.22(b)(2)(ii) requires that to oversee the use of licensed material, the licensee's Radiation Safety Committee must review, pursuant to 10 CFR 35.13(b)(1) through (b)(4), on the basis of board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user.

Contrary to the above, the licensee's Radiation Safety Committee did not review the credentials of an individual, as required, and did not approve or disapprove of the individual prior to allowing that individual to work as an authorized user from April to November 1, 1995. (02014)

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

C. 10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a 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 licensee's written quality management program in the section titled, "Written Directive" requires that an authorized user date and sign a written directive prior to the administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.

10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical and containing the dosage for any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.

Contrary to the on December 7, 1995, 16 millicuries (582 MBq) of iodine-131, a quantity greater than 30 microcuries, was administered to a patient and a written directive was not prepared for the administration. (03014)

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

D. 10 CFR 35.14 requires, in part, that a licensee notify the NRC by letter within 30 days when an authorized user discontinues performance of duties under the license.

Contrary to the above, from October 1993 to April 1995, seven authorized users permanently discontinued performance of duties under the license and the licensee did not notify the NRC until December 22, 1995, a period in excess of 30 days. (04014)

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

Pursuant to the provisions of 10 CFR 2.201, Washington County Memorial Hospital (Licensee) 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 III, 801 Warrenville Road, Lisle, IL 60532-4351 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, (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.

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 placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at Lisle, Illinois
this 2nd day of May 1996