EA-97-038 - Lee, M.D., Philip J. W.
Philip J. W. Lee, M.D.
A.Y. Wong Building
1507 South King Street, Suite 101
Honolulu, Hawaii 96826
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-03545/95-01)
Dear Dr. Lee:
This refers to the March 25, 1997, letter you submitted in response to the apparent violations identified in NRC Inspection Report 030-03545/95-01, issued on March 17, 1997.
The NRC inspection was completed on February 3, 1997. As indicated in the NRC letter transmitting the inspection report, two apparent violations were identified involving your use of NRC-regulated material, i.e., a strontium-90 ophthalmic applicator. You were given a choice of requesting a predecisional enforcement conference or submitting a written response to the apparent violations. You chose to submit a written response.
Based on the information developed during the inspection, and the information that you provided in your March 25 response to the inspection report, the NRC has determined that violations of NRC requirements occurred. The first violation involves a failure to develop and maintain a quality management program (QMP) that included written policies and procedures adequate to ensure that final plans of treatment and related calculations for treatments performed using a strontium-90 ophthalmic applicator were in accordance with the applicable written directives. The failure to have a written procedure for performing decay-correction calculations for your strontium-90 source contributed to an error which resulted in a calculated dose rate that underestimated the actual dose rate from the applicator. In turn, the treatment times were incorrectly calculated, resulting in misadministering radiation to 16 patients (a total of 17 treatments) between May 6 and November 16, 1995, when it was detected by an NRC inspector.
In all 17 treatments, the delivered dose exceeded the prescribed dose by 20 percent or more. As discussed in the inspection report, NRC's medical consultant reviewed the misadministrations and concluded that the affected patients were at risk, although low, for cataract development and that some risk existed for other complications to occur. The error that resulted in the misadministrations appears to have resulted from: (1) your lack of experience in performing such calculations; (2) the lack of a written procedure for performing the calculations; and (3) the lack of accurate reference material on the output of the applicator.
A failure of the quality management program that results in 17 misadministrations is a matter of significant regulatory concern to the NRC. Thus, this violation has been classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600.
In your March 25 letter, you stated that you had the strontium-90 applicator re-calibrated by the National Institute of Standards and Technology in January 1996, made changes to your quality management program to prevent these misadministrations from recurring, and had engaged the services of a certified radiation health physicist, Mr. Scott Dube. The revised procedures you enclosed with your letter state that Mr. Dube will perform annual calculations to correct the output dose rate for decay and determine the time required to deliver a dose of 1000 centigray every March.
In accordance with the NRC Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. Because your facility had not been the subject of escalated enforcement action within the last two inspections (prior to the inspection at issue), 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. Given that the corrective actions described above were prompt and sufficiently comprehensive, credit is due for your corrective actions, resulting in no civil penalty being assessed in this case.
Accordingly, 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, particularly violations of a similar nature, could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action which may subject you to more frequent inspection by NRC.
With respect to this violation, 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 030-03545/95-01 and your letter dated March 25, 1997. Therefore, you are not required to respond to this violation 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.
The second violation involves your failure to provide notification to the affected patients within 24 hours of discovery of the misadministrations discussed above. Although patient notifications were made, they were not made in accordance with NRC requirements because they were made late and did not contain all required information. This violation is being classified at Severity Level IV and requires a response because you did not address it in your March 25 letter.
Therefore, with respect to Violation B, 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 if you choose to submit one, will be placed in the NRC Public Document Room (PDR).
Sincerely, ORG SIGNED BY J. E. DYER FOR Ellis W. Merschoff Regional Administrator
Docket No. 030-03545
License No. 53-04935-01
Enclosure: Notice of Violation
State of Hawaii
Philip J. W. Lee, M.D. Docket No. 030-03545 Honolulu, Hawaii License No. 53-04935-01 EA 97-038
During an NRC inspection completed February 3, 1997, 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.
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 November 15, 1995, the licensee's quality management program did not include a written procedure to meet the objective that finals plans of treatment and related calculations for brachtherapy treatments were in accordance with the applicable written directive. Specifically, the licensee did not have a written procedure for performing decay correction calculations required to determine treatment times for treatments performed using a strontium-90 ophthalmic applicator. As a result, treatment times for 17 treatments were incorrectly calculated and the doses administered in 17 treatments exceeded the intended dose, as documented in the applicable written directives, by greater than 20 percent. (01013)
This is a Severity Level III violation (Supplement VI).
B. 10 CFR 35.33(a)(3) requires, in part, that the licensee notify the referring physician and also notify the individual receiving the misadministration of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgement, telling the individual would be harmful.
10 CFR 35.33(a)(4) requires, in part, that if the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual by sending either a copy of the report that was submitted to the NRC or a brief description of both the event and the consequences as they may affect the individual.
Contrary to the above, on February 6, 1996, the licensee was made aware of 17 misadministrations involving treatments performed using a strontium-90 ophthalmic applicator and the individuals receiving the misadministrations were not notified of the misadministrations until March 21, 1996, a period in excess of 24 hours, and the referring physicians had not informed the licensee that they would inform the individuals or that based on their medical judgement, telling the individuals would have been harmful. In addition, letters sent by the licensee to inform the individuals, dated March 21, 1996, did not include a description of the consequences of the misadministrations. (02014)
This is a Severity Level IV violation (Supplement VI).
With respect to Violation A above, 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 No. 030-03545/95-01 and a letter from Dr. Lee dated March 25, 1997. Therefore, no response to this violation is required. 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, D.C. 20555 with a copy to the Regional Administrator, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.
With respect to Violation B above, and pursuant to the provisions of 10 CFR 2.201, Dr. Lee is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 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, (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.
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. 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.
Dated at Arlington, Texas
this 16th day of April 1997