EA-04-149 - University of Virginia
October 5, 2004
Leonard W. Sandridge, Jr.
Executive Vice President and Chief Operating Officer
University of Virginia
P.O. Box 400228
Charlottesville, VA 22904
|SUBJECT: ||NOTICE OF VIOLATION (NRC Inspection Report No. 030-03296/2004-001) |
Dear Mr. Sandridge:
This letter refers to the NRC inspection conducted between March 15 through 17, 2004, at your facility located in Charlottesville, Virginia, as well as subsequent in-office review of additional information received from your staff between March 19 and May 20, 2004, to review two events that you had reported to the NRC. The events involved (1) the loss of control of iridium-192 at your facility for approximately two hours on February 21, 2004, after it was used to treat a patient; and (2) the administration of iodine-131 to a patient on February 20, 2004, by a technologist without an authorized user's written directive.
Based on the information developed during the inspection, a review of your telephonic reports on February 23, February 24 and March 10, 2004, and a review of your written reports dated March 15 and May 12, 2004, the NRC has determined that four violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violation was discussed by Mr. James Dwyer of the NRC Region I staff, with Dr. Ralph Allen and Ms. Debby Steva of your staff, during an exit meeting on September 7, 2004.
During the September 7, 2004 exit meeting, and during a subsequent conversation on September 14, 2004, Mr. Dwyer indicated that the NRC did not need any additional information to make an enforcement decision regarding the violations. However, Mr. Dwyer provided your staff an opportunity to attend a predecisional enforcement conference or to provide a written response prior to the NRC determining appropriate enforcement action. During these conversations, Dr. Allen and Ms. Steva declined the opportunity to attend a conference or to provide a written response.
The most significant event involved the loss of control of a nylon ribbon containing seven seeds of iridium-192, with a total activity of approximately 5 millicuries, following the removal of several ribbons from a brachytherapy patient. Unknown to the physicians who removed the ribbons, one ribbon fell into the patient's bed. Required surveys of the patient, the patient's bed and room, and the trash receptacles in the room showed no elevated radiation readings, indicating all sources were removed and safely stored in the shielded container. However, because the radiation detection survey instrument used to perform the survey was defective, the ribbon containing the iridium-192 that fell onto the patient's leg remained undetected. The fact that one ribbon was missing was determined a short time later during a required inventory of the sources removed from the patient. By that time, the ribbon had been thrown into the trash and taken, along with waste from the patient's room, to the trash compactor within the facility. The missing ribbon was located two hours later by your staff using a fully functional survey instrument.
The failure to secure the nylon ribbon containing the iridium-192 seeds is a violation of NRC requirements and is a direct result of the failure to perform an adequate survey of the patient and the patient's room, another violation of NRC requirements. Although the material remained in the facility the entire time it was unsecured, and it was unlikely that unauthorized persons came into direct contact with the material, these two violations are of concern to the NRC because (1) the failure to control radioactive material could result in the loss of the material; and (2) such sources can result in substantial unintended radiation dose to an individual if the sources were placed in direct contact with an individual for an extended period of time. Therefore, these two violations are categorized as a Severity Level III problem 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 problem involving the loss of control of radioactive material with this level of radioactivity. 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 were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) removing the defective survey instrument from active use; (2) implementing a more reliable method for performing operability checks of survey equipment; and (3) implementing a new policy requiring the physical presence of a medical physicist during the removal of iridium-192 ribbons from patients.
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 without a civil penalty for this Severity Level III problem. 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.
The second event inspected by the NRC, which concerned an iodine-131 dosage administered to a patient on February 20, 2004, resulted in a Severity Level IV violation of NRC requirements when your technologist administered this dosage without an authorized user's written directive. This violation is fully described in the enclosed inspection report and in the attached Notice.
The three violations noted above are described in Section A of the attached Notice. The NRC has concluded that information regarding the reasons for these three violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in this letter and inspection report. Therefore, you are not required to respond to these violations 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 addition, a fourth violation was also identified during the inspection and involved the failure to immediately notify the NRC of the missing iridium-192 source. Even though your staff eventually notified the NRC, two days elapsed before telephonic notifications occurred. This Severity Level IV violation of NRC requirements is fully described in the enclosed inspection report and in Section B of the attached Notice. You are required to respond to this violation 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 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and 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. To the extent possible, your response should not include any personal privacy, proprietary or safeguards information so that it can be made available to the public without redaction. The NRC also includes Issued Significant Enforcement Actions on its Web site.
| || ||Sincerely, |
| || ||/RA James T. Wiggins Acting For/ |
| || ||Samuel J. Collins |
Docket No. 03003296
License No. 45-00034-26
1. NRC Region I Inspection Report 030-03296/2004-001
2. Notice of Violation
Commonwealth of Virginia
R. Edward Howell
Ralph Allen, Ph.D.
NOTICE OF VIOLATION
|University of Virginia |
| ||Docket No. 030-03296 |
License No. 45-00034-26
During an NRC inspection conducted between March 15 - 17, 2004, as well as an in-office review of additional information provided from the licensee to the NRC between March 19 and May 20, 2004, four violations of NRC requirements were identified. The violations were discussed with the licensee during an exit meeting on September 7, 2004. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are set forth below:
|A. || VIOLATIONS NOT REQUIRING A RESPONSE |
| ||1. || |
10 CFR 35.404(b) requires the licensee to make a survey of the patient with a radiation detection survey instrument immediately after removing the last temporary implant source from the patient to confirm that all sources have been removed.
Contrary to the above, on February 21, 2004, the licensee performed an inadequate survey of a patient after removing the last temporary implant source. Specifically, a radiation detection survey instrument, which was known to function intermittently, was used to survey the patient. As a result, the survey failed to confirm that all sources had been removed from the patients' room.
| ||2. || |
10 CFR 20.1802 requires the licensee to control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
Contrary to the above, for approximately two hours on February 21, 2004, the licensee did not control and maintain constant surveillance of licensed material in a controlled or unrestricted area that was not in storage. Specifically, on that date, a nylon ribbon containing seven seeds of iridium-192 (approximately 5 millicuries) was removed from the patient's room (which was a controlled or unrestricted area), was placed with other trash by the housekeeping staff, and was no longer under the licensee's control or surveillance. This licensed material was missing for approximately two hours before being found in the hospital's trash compactor.
| ||These violations have been categorized as a Severity Level III problem (Supplement IV). |
| ||3. || |
10 CFR 35.27(a)(2) requires, in part, a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user, to require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written directive procedures and the regulations in 10 CFR Part 35.
The written directive procedures established by the licensee and the authorized user required that all administrations of radiopharmaceuticals containing more than 30 microcuries of iodine-131 or iodine-125 must be specifically ordered and approved by the radiologists who are authorized by the University's Radiation Safety Committee to administer radiation to humans (henceforth referred to in the procedures as the authorized user). The written directive will consist of the form entitled "Iodinated, Therapeutic & Research Compound Administration Form," which must be signed and dated by an authorized user.
10 CFR 35.40(a) requires, in part, that a written directive be dated and signed by an authorized user before the administration of iodine-131 sodium iodide dosages greater than 30 microcuries.
Contrary to the above, on February 20, 2004, the licensee permitted the use of byproduct material (iodine-131 sodium iodide dosage greater than 30 millicuries) by an individual under the supervision of an authorized user, and the supervised user did not have a dated and signed written directive before administration.
| ||This is a Severity Level IV violation (Supplement VI). |
|B. ||VIOLATION REQUIRING A RESPONSE |
| ||1. || |
10 CFR 20.2201(a)(1)(i) requires each licensee to report to the NRC by telephone, immediately after its occurrence becomes known to the licensee, any lost, stolen or missing licensed material in an aggregate quantity equal to or greater than 1000 times the quantity specified in Appendix C to Part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas.
Appendix C to Part 20 lists a value of 1.0 microcurie for iridium-192.
Contrary to the above, on February 21, 2004, the licensee became aware that licensed material, in an aggregate quantity greater than 1000 times the quantity specified in Appendix C to Part 20 (specifically 5 millicuries of iridium-192), was missing under such circumstances that it appeared that an exposure could result to persons in unrestricted areas, and the licensee did not report this information to the NRC until February 23, 2004.
| ||This is a Severity Level IV violation (Supplement IV). |
For the three violations listed in Part A , the NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in this letter and NRC Inspection Report No. 030-03296/2004-001. 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 04-149" 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).
For the violation listed in Part B, pursuant to the provisions of 10 CFR 2.201, the University of Virginia is hereby required to submit a written statement or explanation 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). This reply should be clearly marked as a "Reply to a Notice of Violation; EA-04-149" and should include: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (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 any of the violations, 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.
Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. 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. 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 2.390(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 5th day of October 2004
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