EA-00-059 - Hawaiian Eye Clinic and Surgicenter

July 25, 2000

EA-00-059

Dr. Christopher M. Tortora
Medical Director
John M. Corboy, M.D., Inc.
dba Hawaiian Eye Clinic and Surgicenter
606 Kilani Avenue
Wahiawa, Hawaii 96786

SUBJECT:

NOTICE OF VIOLATION; EXERCISE OF ENFORCEMENT DISCRETION; AND TERMINATION OF NRC LICENSE (NRC Inspection Report No. 030-14891/99-01)

Dear Dr. Tortora:

This refers to the letter dated June 14, 2000, in which Dr. Corboy responded on behalf of your organization to the NRC's May 16, 2000 letter and inspection report. Our letter and inspection report described three apparent violations which were being considered for enforcement action, included a Notice of Violation for five violations of NRC requirements associated with your use and transport of NRC-licensed materials, and requested that you provide additional information regarding patient notification issues. Your response letter addressed each of these issues and the final resolution of each is discussed below. This letter also responds to your July 8, 1999 request to terminate your NRC license.

With regard to the apparent violations described in our inspection report, you were asked to provide specific information in response to each to assist the NRC in making an enforcement decision. The apparent violations involved your use of strontium-90 (Sr-90) eye applicators for treatment of superficial eye diseases and included: 1) a failure of your quality management program (QMP) to assure that final treatment plans and related calculations were in accordance with written directives; 2) a failure of your QMP to identify and evaluate deviations from written directives; and 3) a failure of an authorized user to require a supervised physician to follow the authorized user's instructions with regard to patient treatments. Details of the apparent violations are contained in our inspection report. In your response you acknowledged the first two apparent violations but disagreed with the third apparent violation, noting that the authorized user was not aware the supervised physician failed to follow his instructions. We note your disagreement, but conclude that the requirement was violated because it places the responsibility on the licensee to require, and therefore assure, that the authorized user's instructions are followed.

Thus, based on the information developed during our inspection and our review of the information you provided in response, we conclude that each of these violations occurred. The first two are closely related and indicate a programmatic failure of your QMP, which resulted in numerous instances of patients receiving less than the prescribed radiation dose (in one case, it appears that a patient may have received more than the prescribed radiation dose). These misadministrations resulted from a failure to adjust treatment times for radioactive decay of your Sr-90 eye applicators. Thus, in accordance with the General Statement of Policy and Procedure for NRC Enforcement Actions (Enforcement Policy), these violations are appropriately classified as a Severity Level II problem, which we discuss further below. The remaining violation involved a failure of an individual physician to follow an authorized user's instructions on three occasions, which did not represent a programmatic failure. Thus, this violation is appropriately classified at Severity Level IV.

Any violation or combination of violations classified at Severity Level II is a candiate for a monetary civil penalty, and in this case would have resulted in a civil penalty based on NRC having identified the failure to account for radioactive decay of the Sr-90 eye applicators. However, given that you voluntarily suspended your use of Sr-90 eye applicators in January 1999, transferred the applicators, and requested termination of your NRC license, we are exercising our discretion, as provided in Section VII.B.6 of our Enforcement Policy, not to assess a civil penalty. In addition, based on the termination of your license, discussed below, you are not required to provide any further response to the violations in the enclosure. However, you are advised that should you become involved in NRC-licensed activities in the future, you may be required to address the issues in the enclosed Notice of Violation to provide NRC with reasonable assurance that you will comply with NRC requirements.

With regard to the five violations that were cited in a Notice of Violation enclosed with the inspection report, you acknowledged most of the violations but disagreed with certain aspects of Violation B.2 involving the transportation of Sr-90 eye applicators. The NRC notes your disagreement, but does not find the information that you provided sufficient for us to withdraw the violations. Since you are terminating your NRC license, we are not requesting any additional information and consider these violations closed.

With regard to patient notification issues, we found your response satisfactory and have no further questions on that matter.

Finally, with respect to the termination of your NRC license, we intentionally delayed acting on your July 8, 1999 request until we completed our enforcement actions. The NRC has reviewed your sealed source leak test results and concludes that: 1) all licensable radioactive material has been removed from your facility: and 2) residual radioactive material attributable to licensed activities does not exceed current NRC criteria. Based on these conclusions, no further remediation or actions with respect to NRC-regulated material is required. Your facility is suitable for unrestricted use and NRC license number 53-18343-01 for your facility at 606 Kilani Avenue, Wahiawa, Hawaii, is hereby terminated.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be 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. 030-14891
License No. 53-18343-01

Enclosure: Notice of Violation

cc w/Enclosure: State of Hawaii

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NOTICE OF VIOLATION

John M. Corboy, M.D., Inc. (dba Hawaiian Eye Clinic) Wahiawa, Hawaii

Docket No. 030-14891 License No. 53-18343-01 EA-00-059

During an NRC inspection completed March 28, 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.
	1.	Pursuant to 10 CFR 35.32(a)(3), the quality management program must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with a written directive, which is defined in 10 CFR 35.2. Contrary to the above, as of January 13, 1999, the licensee's quality management program did not include a written procedure to meet the objective that final plans of treatment and related calculations for brachytherapy were in accordance with a written directive. Specifically, the licensee's quality management program did not account for radioactive decay of strontium-90 used in eye applicators. As a result, the incorrect source strength was used to determine treatment times, resulting in at least 71 misadministrations (involving 54 different patients).
	2.	Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken. Contrary to the above, as of January 13, 1999, the licensee's quality management program did not include a written procedure to meet the objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
These violations represent a Severity Level II problem (Supplement VI).
B.	1 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user shall require the supervised individual to follow the instructions of the supervising authorized user. The instructions of the supervising authorized user, provided in written directives for treatments using a strontium-90 eye applicator on August 20, September 17, and September 24, 1998, specified that treatment be performed 16 seconds at each of two specified sites on the surface of the eye. Cotrary to the above, on the dates noted above, an individual working under the supervision of the licensee's authorized user treated patients with a strontium-90 eye applicator for less than 16 seconds at each of two specified sites on the surface of the eye.
This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that no response to this Notice of Violation is necessary since License No. 53-18343-01 is being terminated on this same date. However, 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 choose to respond, your response will be made available to the Public. 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.

Dated this 25th day of July 2000.