EA-02-244 - Washington Hospital
November 26, 2002
Anthony P. Zelenka
Vice President, Clinical Support
The Washington Hospital
155 Wilson Avenue
Washington, PA 15301
|SUBJECT:||NOTICE OF VIOLATION (NRC Inspection Report 03003126/2002-001)|
Dear Mr. Zelenka:
This refers to the NRC inspection conducted on September 16 and 17, 2002, at your facility in Washington, Pennsylvania, to review the activities authorized by your NRC license. The inspection was continued in the NRC Region I Office until November 12, 2002, to examine additional information provided by Washington Hospital during telephone conversations between Mr. David Everhart and Mr. Frank Ottino of your staff. During the inspection, apparent violations of NRC requirements were identified. The apparent violations, which were described to you during an exit interview on September 17, 2002, and by telephone on November 12, 2002, involved two examples of improper preparation of written directives on multiple occasions and one example of the failure to conduct an annual review of your Quality Management Program (QMP).
On November 21, 2002, Ms. Pamela Henderson of the NRC Region I staff, held a telephone conversation with you, indicating that the NRC did not need any additional information to make an enforcement decision regarding these violations. However, Ms. Henderson provided you an opportunity to attend a predecisional enforcement conference or to 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, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and are described in detail in the subject inspection report. The first violation involved two examples of the failure to properly prepare written directives on multiple occasions for brachytherapy treatments performed between January 2001 and August 2002. The second violation involved the failure to conduct a review to verify compliance with the QMP at intervals no greater than 12 months.
With respect to the first violation, between January 2001 and April 2001, written directives for brachytherapy procedures were not properly prepared in that the written directives did not contain: (a) prior to administration, the source strengths; and (b) after implantation, but prior to completion of the procedure, the radioisotope and the treatment site. Further, between April 2001 and August 2002, written directives were not properly prepared prior to brachytherapy treatments. NRC regulations permit the licensee flexibility concerning the form of a written directive, as long as it contains the required information and is properly dated and signed. Therefore, information required to be in a written directive can be contained in the patients' files. However, the information in your patient files did not constitute written directives because only some of the required information was present. Other required information, such as the date and signature of the authorized user and the number of sources and source strengths was not included.
Your subsequent review of the procedures did not identify any discrepancies between the intended and the actual administered doses. As such, it is not likely that you had any misadministrations, and there were no actual safety consequences noted from this failure to properly prepare written directives. However, this violation represented a substantial failure to implement the QMP given that the examples comprising this violation repeatedly occurred for approximately 20 months. As a result of this violation, there was an increased potential for any misadministrations going undetected during this time period . Therefore, this violation is categorized at Severity Level III in accordance with the "General Statement of Policy and Procedure 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. Because your facility has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, once the violations were identified during the inspection, were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) development of specific forms to be used for written directives to ensure that all required information is recorded, (2) providing training to the authorized users, including training on the requirement to use the specific forms for written directives for brachytherapy treatments, and (3) performance of a comprehensive retrospective audit of brachytherapy treatments administered during the period to ensure that there were no misadministrations.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation for the Severity Level III violation with no civil penalty. However, you should be aware that significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort. Also, please note that the requirements addressed above and in the enclosed notice of violation concerning the preparation of a written directive are retained in section §35.40 of the revised 10 CFR Part 35 (effective October 24, 2002).
The second violation involving the failure to conduct a review to verify compliance with the QMP at intervals no greater than 12 months, is also described in the enclosed Notice and is classified at Severity Level IV.
The NRC has concluded that information regarding your corrective actions taken and planned to correct the violations and prevent recurrence have been described as documented in this letter and the subject inspection report. 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. We appreciate your cooperation with us in this matter. In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (if you choose to provide one) 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.
|/RA/ James T. Wiggins Acting For|
|Hubert J. Miller
Docket No. 03003126
License No. 37-10363-01
1. Notice of Violation
2. NRC Region I Inspection Report 03003126/2002-001
cc w/encl: Commonwealth of Pennsylvania
NOTICE OF VIOLATION
|Docket No. 03003126
License No. 37-10363-01
During an NRC inspection conducted on September 16 and 17, 2002, and continued in the NRC Region I Office until November 12, 2002, two violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:
10 CFR 35.32(a)(1) requires, in part, that the licensee establish and maintain a quality management program which must include written policies and procedures to meet the objective that, prior to administration, a written directive is prepared for any brachytherapy radiation dose.
10 CFR 35.2 defines a written directive as an order, in writing, for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain information including for brachytherapy, prior to administration, the number of sources and source strengths and after implantation, but prior to completion of the procedure, the radioisotope, the treatment site and total source strength and exposure time (or equivalently, the total dose).
Contrary to the above, the licensee did not maintain a quality management program to meet the objective that, prior to administration, a written directive is prepared for any brachytherapy radiation dose. Specifically, the licensee did not provide all required information in the written directive, as evidenced in the following examples;
|1.||Three written directive forms prepared for brachytherapy procedures between January 2001 and April 2001, did not include (a) prior to administration, the source strengths; and (b) after implantation, but prior to completion of the procedure, the radioisotope and treatment site.|
|2.||The licensee performed 14 brachytherapy procedures from April 2001 to August 2002, and the written directives (orders contained in patients' files) for these brachytherapy radiation doses did not include the date and signature of an authorized user, and the number of sources and source strengths, prior to the administration.|
|This is a Severity Level III violation (Supplement VI ).|
10 CFR 35.32(b) requires, in part, that the licensee develop procedures for and conduct a review to verify compliance with all aspects of the quality management program at intervals no greater than 12 months.
Contrary to the above, the licensee did not conduct a review to verify compliance with the quality management program between March 2001 and October 2002, an interval greater than 12 months.
This is a Severity Level IV violation (Supplement VI).
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 are already adequately addressed on the docket in the NRC letter transmitting this Notice. 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, EA 02-244" 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 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.
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.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 26th day of November 2002