EA-02-150 - Danbury Hospital
August 5, 2002
Patricia A. O'Connor
Senior Vice President - Operations
24 Hospital Avenue
Danbury, CT 06810-6099
|SUBJECT:||NOTICE OF VIOLATION (NRC Inspection Report No. 03001274/2002001)|
Dear Ms. O'Connor:
This refers to the NRC inspection initiated on February 28, 2002, at Danbury Hospital in Danbury, Connecticut, to review the circumstances associated with a misadministration which occurred at the facility during a brachytherapy treatment administered to a patient on February 20 - 22, 2002. On February 27, 2002, your staff provided a written report to the NRC regarding the event. The NRC inspection continued until May 24, 2002, during which time a medical consultant (retained by the NRC) reviewed the circumstances surrounding the misadministration. The subject inspection report is attached.
During this inspection, one apparent violation of NRC requirements was identified which was related to the misadministration. On July 23, 2002, Ms. Pamela Henderson of the NRC Region I staff, held a telephone conversation with you and Ms. Cammie Gee of your staff, indicating that the NRC did not need any additional information to make an enforcement decision regarding this violation. However, Ms. Henderson provided you an opportunity to attend a predecisional enforcement conference or provide a written response prior to the NRC determining appropriate enforcement action in this case. During that conversation, you declined the opportunity to attend a conference or to provide a written response.
Based on the information developed during the inspection, and information contained in your February 27, 2002 report, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the surrounding circumstances are described in detail in the subject inspection report. The violation involved a deficiency in the Quality Management Program (QMP) in that the QMP did not include a procedure to ensure that all sources intended for implantation in patients during brachytherapy treatments were, in fact, implanted in accordance with the written directive of the authorized user.
As a result of this deficiency in the QMP, your staff failed to detect that only four of the five intended cesium-137 sources were implanted into the patient as part of the treatment administered on February 20-22, 2002. The fifth source was presumably not implanted into the patient on February 20, 2002, because it was subsequently found in a trash can in the patient's room on February 22, 2002, after the other four sources were removed from the patient. Since the source remained in the patient's room (a controlled area) during the treatment, there were no significant additional exposures to the hospital staff or the public from the source in the trash can.
The NRC determined that the safety impact on the patient was low in this case since the NRC's medical consultant confirmed your conclusions that the administered doses were within the clinical dose range and there were no adverse effects on the patient. However, you are responsible, through your QMP, for assuring that licensed material is administered correctly by the authorized user. In this case, your QMP failed to provide this assurance, and therefore did not prevent the misadministration. Accordingly, this event has been categorized as a Severity Level III violation in accordance with the "General Statement of Policy for Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 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 Action is warranted because your corrective actions were considered prompt and comprehensive. Specifically, you amended the QMP to require that a physicist observe the source loading in the patients's room to verify that each source has been properly implanted.
Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized to not 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 that may subject you to increased inspection effort.
The NRC has concluded that information regarding your corrective actions taken and planned to correct and prevent recurrence of the violations set forth in the enclosed Notice, has been adequately described 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. We appreciate your cooperation with us in this matter.
A copy of this letter and any reply will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Reading Room).
We appreciate your cooperation with us in this matter.
|/RA/ Original Signed by
|Hubert J. Miller
Docket No. 030-01274
License No. 06-08544-01
1. Notice of Violation
2. NRC Region I Inspection Report 03010274/2002001
NOTICE OF VIOLATION
|Docket No. 03001274
License No. 06-08544-01
EA No. 02-150
During an NRC inspection conducted on February 28, 2002, at Danbury Hospital in Danbury, CT, and continued in the NRC Region I office until May 24, 2002, 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:
|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)(4), the quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with the written directive.
Contrary to the above, as of February 22, 2002, the licensee's quality management program did not include a written procedure to meet the objective that each administration is in accordance with the written directive. Specifically, the licensee did not have a written procedure to ensure that the appropriate sources were implanted as specified in the written directive. Consequently, during a brachytherapy treatment on February 20 - 22, 2002, the licensee failed to detect that only four of the five cesium-137 sources intended for implantation, were actually implanted into the patient. The dose administered (3593 rads) differed from the prescribed dose in the written directive (4600 rads) by approximately 22 percent, and is therefore classified as a misadministration.
This is a Severity Level III violation (Supplement VI).
The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed on the docket in the NRC letter transmitting this Notice. 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 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.
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 or proprietary information so that it can be placed in the PDR without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 5th day of August 2002