United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-98-481 - Audie L. Murphy Memorial Veteran's Hospital

January 17, 1999

EA 98-481

Jose R. Coronado, Director
Department of Veterans Affairs
Audie L. Murphy Memorial Veteran's Hospital
7400 Merton Minter Boulevard
San Antonio, Texas 78284

SUBJECT: NOTICE OF VIOLATION (NRC INSPECTION REPORT 030-09959/98-01)

Dear Mr. Coronado:

This refers to your letter dated January 15, 1999, in response to the subject inspection report dated December 10, 1998. The inspection was an examination of activities conducted under Byproduct Materials License 42-15881-01 as they relate to radiation safety and to compliance with the Commission's rules and regulations and the conditions of the license. After the in-office review of additional documents submitted to the NRC by Audie L. Murphy Memorial Veteran's Hospital (ALMMVH), the inspection was concluded on November 10, 1998, at which time the NRC informed you that it was considering escalated enforcement action for an apparent violation identified during the inspection. You elected to respond to the apparent violation in writing, by your January 15, 1999 letter, in lieu of requesting a predecisional enforcement conference.

Based on the information developed during the inspection, and consideration of the information that you provided in your response to the inspection report, 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 in detail in the subject inspection report. The violation involves the unauthorized use of strontium-90 sealed sources to perform intravascular brachytherapy (IVB) procedures on human subjects under a research protocol on two occasions in March 1998. In August 1998, during discussions about renewing ALMMVH's license, the radiation safety officer (RSO) identified to NRC license reviewers that the hospital had used a Novoste IVB device on humans, under a research protocol, and that the licensee believed that 10 CFR 35.6 permitted the activity. Nevertheless, in spite of your differing interpretation of the regulatory requirements, you agreed to suspend further use of this device and take certain additional actions. Your commitments were described in a Confirmatory Action Letter (CAL 4-98-003) issued by the NRC to your facility on August 28, 1998.

There were no actual safety consequences resulting from the violation. The inspection found that appropriate radiation safety procedures were utilized by ALMMVH during use of the device. These included conducting radiation surveys, verifying patient identification, verifying treatment sites and prescribed doses, implementing device quality control procedures, ensuring emergency equipment availability and ensuring the presence of a radiation oncologist, cardiologist, and medical physicist throughout the procedure. However, the significance of the violation rests with the fact that a device used to perform IVB procedures on human subjects had not undergone a safety (engineering) evaluation pursuant to 10 CFR 32.210 and was not listed on a registration certificate issued by the NRC or an Agreement State. This evaluation is especially important given that the FDA considers IVB procedures conducted under a research protocol a high risk activity and that some misadministrations have occurred while using this device as a result of failing to position the sources precisely. As such, 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 civil penalty with a base value 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.B.2 of the Enforcement Policy. ALMMVH's corrective actions included immediately suspending IVB research, returning the sealed sources to the manufacturer, and discussing NRC regulations and the ALMMVH's license, regarding research on humans, with the ALMMVH radiation safety committee. The NRC has determined that ALMMVH is deserving of corrective action credit, resulting in no civil penalty being assessed.

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, which 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 Inspection Report 030-09959/98-01 and in your letter dated January 15, 1999. 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 respond, will be placed in the NRC Public Document Room.

Sincerely,

Org signed by T. P. Gwynn

Ellis W. Merschoff
Regional Administrator


Docket No. 030-09959
License No. 42-15881-01

Enclosure: Notice of Violation

cc (w/encl):
Texas Radiation Control Program Director
Dr. Milton Gross
Department of Veterans Affairs
Nuclear Medicine Program
24 Frank Loyd Wright Drive
Lobby M, P. O. Box 505
Ann Arbor, Michigan 48105


ENCLOSURE

NOTICE OF VIOLATION



Department of Veterans Affairs
Audie L. Murphy Memorial Veteran's Hospital
San Antonio, Texas

Docket No. 030-09959
License No. 42-15881-01
EA 98-481

During an NRC inspection completed November 10, 1998, 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 30.34(c) requires, in part, that each licensee confine its possession and use of byproduct materials to the locations and purposes authorized by the license.

License No. 42-15881-01, conditions 9.G. and 9.H., authorize research and development as defined in Section 30.4(q), 10 CFR Part 30 (currently 10 CFR 30.4), in vitro studies, and tracer studies in humans as approved by the licensee's Radioactive Drug and Research Committee No. RDRC 0056.

10 CFR 30.4 states, in part, that "Research and development" as used in this part and parts 31 through 35 does not include the internal or external administration of byproduct material, or the radiation therefrom, to human beings.

Contrary to the above, on March 3 and 4, 1998, the licensee did not confine its use of byproduct materials to the purposes authorized by the license. Specifically, the licensee used strontium-90 sealed sources to perform intravascular brachytherapy procedures, an internal administration of byproduct material on human subjects. (01013)

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 030-09959/98-01 and letter from Licensee dated January 15, 1999. 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, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, and a copy to the NRC Resident Inspector at the facility that is the subject of this Notice, 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, this response shall be submitted under oath or affirmation.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

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

Dated this 17th day of February 1999

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