EA-00-245 - Sibley Memorial Hospital
February 26, 2001
Mr. Robert L. Sloan
Chief Executive Officer
Sibley Memorial Hospital
5255 Loughboro Road, N.W.
Washington, DC 20016-2695
|SUBJECT:||NOTICE OF VIOLATION (NRC Inspection Report No. 030-14754/00-01)|
Dear Mr. Sloan:
This refers to the NRC inspection conducted on September 28 and 29, 2000, at your facility in Washington, DC to review the circumstances associated with the misadministration of iodine-125 to two patients at your facility during September 15 - 20, 2000. The misadministrations were reported to the NRC via telephone by your staff on September 22, 2000. The inspection was continued in the Region I office on January 29, 2001, to review the results of a report, received on that date, from an NRC medical consultant who reviewed the circumstances and significance associated with the these misadministrations. During the inspection, one apparent violation of NRC requirements was identified. The apparent violation was described in our inspection report sent to you on January 31, 2001. On February 21, 2001, a predecisional enforcement conference was held with Mr. Jerry Price and other members of your staff to discuss the apparent violation, its causes, and your corrective actions. A copy of the enforcement conference report will be sent under separate cover.
Based on the information developed during the inspection, the information provided in your September 25, 2000 report to the NRC, and the information obtained during the predecisional enforcement conference, a violation of NRC requirements is being cited. The violation is described in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved the failure of your Quality Management Program (QMP) to include adequate written procedures for appropriate use of dose-to-activity conversion factors to assure that correct strength sources are ordered from the vendor for the planned treatment. As a result, doses were administered to patients at the facility without proper review of the written directives prior to the administrations. This violation contributed to the two misadministrations which occurred when the two patients, who were to be given eye treatments via temporary brachytherapy implant procedures, were administered doses of iodine-125 approximately 50% higher than intended.
The administration of wrong dose amounts to the two patients occurred after a calculation error was made by the dosimetrist who ordered the iodine-125. Subsequently, the Medical Physicist and the responsible physician failed to recognize the error in the written directives. Although adverse health impacts from the misadministrations are unlikely, this finding, nonetheless, represents a programmatic weakness in the implementation of your QMP which resulted in the misadministrations. Therefore, the violation is categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 (May 1, 2000 (65 FRN 25368)). The Enforcement Policy is available at the Office of Enforcement website.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years, 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 for corrective actions is warranted because your corrective actions, at the time of the predecisional enforcement conference, were considered prompt and comprehensive. These actions included, but are not limited to: (1) revision of the procedures for eye treatments with brachytherapy implants to ensure that the required activity is ordered and administered in a consistent manner (for example, changes were made such that all prescribed doses are the same amount; all prescribed treatment periods are the same; and all eye implants use the same type of I-125 seed); (2) changes to the policy for ordering source material and verifying the proper dosage to ensure that only the medical physicist performs those activities; and (3) implementation of a policy for review of written directives to include an explicit requirement that treatment parameters and calculations be reviewed by an independent physician before the third day of treatment.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described adequately during the enforcement conference, and are adequately addressed on the docket in your report, dated September 25, 2000, or in this letter. Therefore, you are not required to respond to this letter unless the description herein 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 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.
|/RA/ James T. Wiggins Acting for
|Hubert J. Miller
Docket No. 030-14754
License No. 08-07398-03
Enclosure: Notice of Violation
cc w/encl: District of Columbia
NOTICE OF VIOLATION
|Sibley Memorial Hospital
|Docket No. 030-14754
License No. 08-07398-03
During an NRC inspection conducted on September 28 and 29, 2000, at the licensee's facility in Washington, DC, and continued in the Region I office on January 29, 2001, to review the results of an NRC Medical Consultant's report, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is listed below:
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)(4), the quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with a written directive, which is defined in 10 CFR 35.2.
Contrary to the above, as of September 29, 2000, the licensee's quality management program did not include an adequate written procedure to meet the objective that each administration is in accordance with a written directive. Specifically, the licensee's quality management program did not include an adequate written procedure for appropriate use of dose-to-activity conversion factors to assure that correct strength sources are ordered from the vendor for the planned treatment. Consequently, two patients that were treated between September 15-20, 2000, were implanted with higher activity sources than intended, which resulted in misadministrations when one patient was administered a dose of 11,471 centiGray (cGy) and the other patient was administered 10,866 cGy, instead of the prescribed dose of 7000 cGy in each case.
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 September 25, 2000 letter, or in the letter transmitting this Notice which summarizes the information provided during the enforcement conference. Therefore, no response to this Notice 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, DC 20555 with a copy to the Regional Administrator, Region I, 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 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. 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 26th day of February 2001