EA-01-157 - Providence Hospital
March 22, 2002
Sister Carol Keehan
Office of the President
1150 Varnum Street
Washington, DC 20017
|SUBJECT:||NOTICE OF VIOLATION|
(NRC Inspection Report No. 030-01316/01-01)
Dear Sister Keehan:
This refers to the inspection conducted on May 22-23, 2001, at Providence Hospital in Washington, DC. The inspection was performed to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. During this inspection, four apparent violations of NRC requirements were identified with respect to your strontium-90 (Sr-90) eye applicator program. On June 1, 2001, the NRC issued a Confirmatory Action Letter (CAL) to address the related deficiencies. Following your review of the related violations, you notified the NRC on August 24, 2001, that there were 14 misadministrations at your facility because outdated calibration data, used to calculate patient treatments, resulted in actual doses that exceeded the planned doses by more than 20 percent.
The NRC inspection continued through January 11, 2002, while a medical consultant, retained by the NRC, reviewed the circumstances surrounding the misadministrations. The NRC consultant agreed with your assessment that 14 misadministrations had occurred. The subject inspection report was forwarded to you on February 6, 2002. On February 20, 2002, a predecisional enforcement conference was conducted with members of your staff to discuss the apparent violations, their causes, and your corrective actions, including long term actions planned to prevent recurrence. A summary of the enforcement conference is attached.
Based on the information developed during the inspection, information received from your correspondence dated September 3, 2001, September 17, 2001, and November 30, 2001, and information you provided during the predecisional enforcement conference, the NRC has determined that five violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the surrounding circumstances are described in detail in the subject inspection report. The violations involved failure to: (1) verify that the final plans of treatment were consistent with the respective written directives prior to administering the treatments; (2) review the calculations for increased application time prior to application; (3) provide procedures in the Quality Management Program (QMP) that identify and evaluate any unintended deviations from the written directives; (4) oversee the use of licensee material through an annual review of the radiation safety program by the Radiation Safety Committee; and, (5) conduct audits of the QMP for 1998, 1999, and 2000 for the strontium-90 eye treatments. During the conference, you stated that the root causes of the misadministrations were: (1) an incorrect calibration chart; (2) arithmetic errors made by the authorized user; and, (3) the Radiation Safety Committee not questioning the scope of the annual audits because of the expertise of the auditor.
The NRC determined that the safety impact on the patients 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 patients. 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 this failure resulted in misadministrations. Therefore, these violations have been categorized as a Severity Level III problem 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, at the time of the predecisional enforcement conference, were considered prompt and comprehensive. These actions included, but are not limited to: (1) recalibration of the applicator with a tip shield; (2) recalculation of the administered dose to patients based on the new calibration; (3) counseling the authorized user; (4) development of a form requiring a second person to check the dose calculations prior to treatment; (5) revision of the annual audit procedures and forms to reduce the possibility of missing misadministration errors; (6) plans for providing training to the staff on regulatory requirements; (7) plans to assess the purpose and conduct of your Radiation Safety Committee for ensuring the proper oversight of all NRC licensed activities; and (8) plans to assess other aspects of your program to assure similar problems do not exist in those areas.
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 problem constitutes escalated enforcement action, that may subject you to increased inspection effort.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. Although this letter describes the corrective actions you have taken to date, your response should address the current status of your plans for: (1) providing training to your staff; (2) assessing the conduct of the Radiation Safety Committee; and, (3) reviewing other areas of your program for similar problems. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
A copy of this letter and your 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/ James T. Wiggins Acting For|
|Hubert J. Miller|
Docket No. 030-001316
License No. 08-01728-01
1. Notice of Violation
2. Enforcement Conference Summary
NOTICE OF VIOLATION
|Docket No. 03001316 |
License No. 08-01728-01
During an NRC inspection conducted on May 22 and 23, 2001, at Providence Hospital in Washington, D.C., and continued in the NRC Region I office until January 11,2002, five 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:
|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
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 are in accordance with a written directive, which is defined in 10 CFR 35.2.
|1.||Objective 1, Item C, of the licensee's quality management
program dated November 20, 1995, requires the use of a decay chart to
calculate the increased application time due to a reduction in source
strength from radioactive decay.|
Contrary to the above, as of May 23, 2001, 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 are in accordance with the written directive. Specifically, the licensee did not verify the validity of the Strontium-90 eye applicator decay chart and did not possess any source output calibration certificate. The decay chart used to calculate the application time was incorrect, as determined by a subsequent calibration of the applicator. Consequently, the calculated administered doses exceeded the doses prescribed in the written directives by 22 to 35 percent, resulting in 14 misadministrations.
|2.||Objective 3 of the licensee's quality management program dated
November 20, 1995, requires that the calculations for the increased
application time are reviewed by the user prior to
Contrary to the above, as of May 23, 2001, the licensee failed to review calculations for the increased exposure time prior to the applications. Specifically, the authorized user did not review calculations related to final plans of treatment. As a result, arithmetic errors in the calculations for application time were not identified prior to some applications.
|3.||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 May 23, 2001, the licensee's quality management program did not include written policies and procedures to meet the objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken. Specifically, only unintended deviations for time of application were considered in the licensee's quality management program.
|B.||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
Contrary to the above, as of May 23, 2001, the licensee did not develop procedures for and conduct a review to verify compliance with all aspects of the quality management program. As a result, the quality management program for strontium-90 was not reviewed since at least 1998.
|C.||10 CFR 35.22(b)(6) requires that, to oversee the use of
licensed material, the Radiation Safety Committee must review annually,
with the assistance of the Radiation Safety Officer, the radiation safety
Contrary to the above, from January 1998 to May 2001, the licensee's Radiation Safety Committee did not review, with the assistance of the Radiation Safety Officer, the licensee's radiation safety program for its strontium-90 eye applicator.
This is a Severity Level III problem (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Providence Hospital 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 I, 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.
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.
Because 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), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library). 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.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 22nd day of March 2002